Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT05148234
Status:
TERMINATED
Last Update Posted:
2025-09-30
First Post:
2021-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BMS-986253 in Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D000095542', 'term': 'Cytopenia'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004247', 'term': 'DNA'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'C000633944', 'term': 'cedazuridine'}, {'id': 'C000709704', 'term': 'HuMax-IL8'}, {'id': 'D016209', 'term': 'Interleukin-8'}], 'ancestors': [{'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D019743', 'term': 'Chemokines, CXC'}, {'id': 'D018925', 'term': 'Chemokines'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D002630', 'term': 'Chemotactic Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'najla.eljurdi@nih.gov', 'phone': '240-992-4033', 'title': 'Dr. Najla El Jurdi', 'organization': 'National Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.', 'description': '1/2 participants were enrolled but not treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase I: Optimal Biological Dose (OBD) for Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Phase I Dose Level 1: All participants who received at least on dose of drug.'}], 'classes': [{'title': 'With DNMTi', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the maximum tolerated doses. There is not enough data to determine OBD.', 'groupId': 'OG000'}]}]}, {'title': 'Without DNMTi', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the maximum tolerated doses. There is not enough data to determine OBD.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28 days (C1D28) on up to 30 days.', 'description': "OBD of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). DLT is defined as any of the following: any grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal. OBD is the lowest tolerated dose level showing optimal biological activity, defined as maximal suppression of serum free IL-8 levels. The goal is to achieve IL-8 levels below the lower limit of detection of the assay in real time by Ultrasensitive immunoassay based on Quanterix Simoa technology. The lower limit of quantification = 0.86 pg/mL by Myriad-Rules Based Medicine (RBM).", 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': '1/2 participants were enrolled but not treated.'}, {'type': 'PRIMARY', 'title': 'Phase I: Recommended Phase 2 Dose (RP2D) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Phase I Dose Level 1: All participants who received at least on dose of drug.'}], 'classes': [{'title': 'With DNMTi', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the Recommended Phase 2 Dose (RP2D). There is not enough data to determine MTD.', 'groupId': 'OG000'}]}]}, {'title': 'Without DNMTi', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the Recommended Phase 2 Dose (RP2D). There is not enough data to determine MTD.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28 days (C1D28)', 'description': "RP2D of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose -limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). RP2D is defined as the optimal biological dose expected to be safe and of potential efficacy. It serves as a starting point for further investigations in future phase 2 clinical trials. DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal.", 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': '1/2 participants were enrolled but not treated.'}, {'type': 'PRIMARY', 'title': 'Phase II: Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'title': 'CR With DNMTi'}, {'title': 'CR Without DNMTI'}, {'title': 'PR With DNMTi'}, {'title': 'PR Without DNMTI'}], 'timeFrame': '6 months', 'description': 'Overall response rate (ORR= Complete Remission (CR) + Partial Remission (PR) + \\[marrow CR + hematologic improvement (HI\\]) of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) after 6 cycles of therapy was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'title': 'Grades 1-5 Serious related to BMS-986253', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grades 1-5 Non-serious related to BMS-986253', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1 -2 Serious related to DNMTi', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Serious related to DNMTi - Febrile neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Serious related to DNMTi - Skin infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2 Non-serious related to DNMTi - Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Non-serious related to DNMTi - White blood cell decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28 days and follow up after the end of the treatment cycle; approximately 2 months.', 'description': 'Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': '1/2 participants were enrolled but not treated.'}, {'type': 'PRIMARY', 'title': 'Phase II: Fraction of Participants With Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cycles', 'description': 'Clinical response was assessed by the assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes and reported with 95% confidence interval. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant. Stable disease is failure to achieve at least PR, but no evidence of progression for \\>8 weeks. Progression is less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; transfusion dependence. Relapse after CR or PR is at least 1 of the following: return to pre-treatment bone marrow blast percentage or decrement of ≥50% from maximum remission/response levels in granulocytes or platelets.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase I: Area Under the Concentration Time Curve (AUC 0-24h) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes (MDS) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'title': 'With DNMTi'}, {'title': 'Without DNMTi'}], 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'AUC is a measure of the serum concentration of drug BMS-986253 over time. It is used to characterize drug absorption.', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.'}, {'type': 'SECONDARY', 'title': 'Phase I: Half-life of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'title': 'With DNMTi'}, {'title': 'Without DNMTi'}], 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.'}, {'type': 'SECONDARY', 'title': 'Phase I: Concentration of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) at Steady State With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'title': 'With DNMTi'}, {'title': 'Without DNMTi'}], 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'Concentration of BMS-986253 at steady state in plasma.', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.'}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': '1 year', 'description': 'Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Cytogenetic Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cycles', 'description': 'Cytogenetic Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Cytogenetic complete response is disappearance of the chromosomal abnormality without appearance of new ones. Cytogenetic partial response is at least 50% reduction of the chromosomal abnormality.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to Best Response (Complete Remission (CR), Partial Remission (PR), Marrow CR + Hematologic Improvement (HI), HI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Time to best response', 'description': 'Time to best response (Complete Remission (CR), Partial Remission (PR), marrow CR + HI, HI) using the Kaplan-Meier method. Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant. Hematologic improvement (HI) is defined as: Erythroid response - at least 2 consecutive hemoglobin (hgb) measurements \\>1.5 g/dL for a period of minimum 8 weeks in an observation period of 16-24 weeks compared with the lowest mean of 2 hgb measurements within 16 weeks before treatment onset. Platelet response - absolute increase of 30x10\\^9/L for participants starting with \\>20x10\\^9/L platelets.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Disease Free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Until study closure', 'description': 'DFS is defined as time to relapse for participants who achieve complete remission (CR) using the Kaplan-Meier method. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Until study closure', 'description': 'PFS is defined as disease progression or death from Myelodysplastic Syndromes (MDS). Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \\>20% blasts; 20%-30% blasts: ≥50% increase to \\>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Leukemia Free Survival (LFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Until study closure', 'description': 'LFS is defined as progression to acute myeloid leukemia (AML) or death from any cause using the Kaplan-Meier method. Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \\>20% blasts; 20%-30% blasts: ≥50% increase to \\>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'SECONDARY', 'title': 'Phase II: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'timeFrame': 'Until study closure', 'description': 'OS is defined as death from any cause using the Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because the company closed the study prior to phase II.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first study intervention, study day 1, through study day 100 after the end of the treatment cycle; approximately 7 months.', 'description': 'Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1/2 participants were enrolled but not treated.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase I: Proportion of Participants With Dose-limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28 days', 'description': "DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal.", 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': '1/2 participants were enrolled but not treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I Dose Level -1: 600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}, {'id': 'FG001', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}, {'id': 'FG002', 'title': 'Phase I Dose Level 2: 2400 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}, {'id': 'FG003', 'title': 'Phase I Dose Level 3: 3600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}, {'id': 'FG004', 'title': 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.'}, {'id': 'FG005', 'title': 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.'}, {'id': 'FG006', 'title': 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.'}, {'id': 'FG007', 'title': 'Enrolled But Not Treated', 'description': 'Participant was enrolled but not treated.'}], 'periods': [{'title': 'Phase I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Company closed the trial.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Phase II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.\n\nBMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.'}, {'id': 'BG001', 'title': 'Enrolled But Not Treated', 'description': 'Participant was enrolled but not treated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '0', 'groupId': 'BG000'}, {'value': '44', 'spread': '0', 'groupId': 'BG001'}, {'value': '53.5', 'spread': '13.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Data was collected and reported for one participant enrolled but not treated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-08', 'size': 7691035, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_004.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-11T13:27', 'hasProtocol': True}, {'date': '2023-04-18', 'size': 584385, 'label': 'Informed Consent Form: Cohort Screening Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-18T08:36', 'hasProtocol': False}, {'date': '2023-12-21', 'size': 805978, 'label': 'Informed Consent Form: Cohort Affected Patient, Treatment', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_005.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-11T13:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Company closed the trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2021-12-04', 'resultsFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-05-17', 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)', 'timeFrame': 'From first study intervention, study day 1, through study day 100 after the end of the treatment cycle; approximately 7 months.', 'description': 'Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.'}, {'measure': 'Phase I: Proportion of Participants With Dose-limiting Toxicities (DLT)', 'timeFrame': 'First 28 days', 'description': "DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal."}], 'primaryOutcomes': [{'measure': 'Phase I: Optimal Biological Dose (OBD) for Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)', 'timeFrame': 'First 28 days (C1D28) on up to 30 days.', 'description': "OBD of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). DLT is defined as any of the following: any grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal. OBD is the lowest tolerated dose level showing optimal biological activity, defined as maximal suppression of serum free IL-8 levels. The goal is to achieve IL-8 levels below the lower limit of detection of the assay in real time by Ultrasensitive immunoassay based on Quanterix Simoa technology. The lower limit of quantification = 0.86 pg/mL by Myriad-Rules Based Medicine (RBM)."}, {'measure': 'Phase I: Recommended Phase 2 Dose (RP2D) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)', 'timeFrame': 'First 28 days (C1D28)', 'description': "RP2D of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose -limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). RP2D is defined as the optimal biological dose expected to be safe and of potential efficacy. It serves as a starting point for further investigations in future phase 2 clinical trials. DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal."}, {'measure': 'Phase II: Overall Response Rate', 'timeFrame': '6 months', 'description': 'Overall response rate (ORR= Complete Remission (CR) + Partial Remission (PR) + \\[marrow CR + hematologic improvement (HI\\]) of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) after 6 cycles of therapy was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant.'}, {'measure': 'Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'timeFrame': 'First 28 days and follow up after the end of the treatment cycle; approximately 2 months.', 'description': 'Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Phase II: Fraction of Participants With Clinical Response', 'timeFrame': 'Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cycles', 'description': 'Clinical response was assessed by the assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes and reported with 95% confidence interval. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant. Stable disease is failure to achieve at least PR, but no evidence of progression for \\>8 weeks. Progression is less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; transfusion dependence. Relapse after CR or PR is at least 1 of the following: return to pre-treatment bone marrow blast percentage or decrement of ≥50% from maximum remission/response levels in granulocytes or platelets.'}], 'secondaryOutcomes': [{'measure': 'Phase I: Area Under the Concentration Time Curve (AUC 0-24h) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes (MDS) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'AUC is a measure of the serum concentration of drug BMS-986253 over time. It is used to characterize drug absorption.'}, {'measure': 'Phase I: Half-life of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.'}, {'measure': 'Phase I: Concentration of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) at Steady State With and Without Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'timeFrame': 'Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.', 'description': 'Concentration of BMS-986253 at steady state in plasma.'}, {'measure': 'Phase II: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)', 'timeFrame': '1 year', 'description': 'Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Phase II: Cytogenetic Response Rate', 'timeFrame': 'Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cycles', 'description': 'Cytogenetic Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Cytogenetic complete response is disappearance of the chromosomal abnormality without appearance of new ones. Cytogenetic partial response is at least 50% reduction of the chromosomal abnormality.'}, {'measure': 'Phase II: Time to Best Response (Complete Remission (CR), Partial Remission (PR), Marrow CR + Hematologic Improvement (HI), HI)', 'timeFrame': 'Time to best response', 'description': 'Time to best response (Complete Remission (CR), Partial Remission (PR), marrow CR + HI, HI) using the Kaplan-Meier method. Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \\>5%. And cellularity and morphology not relevant. Hematologic improvement (HI) is defined as: Erythroid response - at least 2 consecutive hemoglobin (hgb) measurements \\>1.5 g/dL for a period of minimum 8 weeks in an observation period of 16-24 weeks compared with the lowest mean of 2 hgb measurements within 16 weeks before treatment onset. Platelet response - absolute increase of 30x10\\^9/L for participants starting with \\>20x10\\^9/L platelets.'}, {'measure': 'Phase II: Disease Free Survival (DFS)', 'timeFrame': 'Until study closure', 'description': 'DFS is defined as time to relapse for participants who achieve complete remission (CR) using the Kaplan-Meier method. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted.'}, {'measure': 'Phase II: Progression Free Survival (PFS)', 'timeFrame': 'Until study closure', 'description': 'PFS is defined as disease progression or death from Myelodysplastic Syndromes (MDS). Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \\>20% blasts; 20%-30% blasts: ≥50% increase to \\>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.'}, {'measure': 'Phase II: Leukemia Free Survival (LFS)', 'timeFrame': 'Until study closure', 'description': 'LFS is defined as progression to acute myeloid leukemia (AML) or death from any cause using the Kaplan-Meier method. Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \\>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \\>20% blasts; 20%-30% blasts: ≥50% increase to \\>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.'}, {'measure': 'Phase II: Overall Survival (OS)', 'timeFrame': 'Until study closure', 'description': 'OS is defined as death from any cause using the Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heterogenous clonal diseases neoplasms', 'Interleukin-8', 'DNA methyltransferase inhibitors', 'cytopenias', 'Allogeneic Hematopoietic Stem Cell Transplantation'], 'conditions': ['Myelodysplastic Syndromes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_000356-C.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe myelodysplastic syndromes (MDS) are a group of bone marrow neoplasms. MDS mostly affect elderly people. The drugs used to treat MDS are not always effective, and the only curative treatment is stem cell transplant. Researchers want to see if a new drug can be used to treat MDS.\n\nObjective:\n\nTo learn if HuMax-interleukin 8 (IL-8) BMS-986253 is a safe and effective treatment for MDS.\n\nEligibility:\n\nAdults aged 18 and older with MDS.\n\nDesign:\n\nParticipants will be screened with a medical history, medication review, and physical exam. They will answer questions about how well they are able to take care of themselves. Their temperature, blood pressure, breathing rate, and heart rate will be monitored. They will have an electrocardiogram to see how well their heart is working. They will give blood and urine samples. They may have a bone marrow biopsy.\n\nParticipants will be assigned to a specific group. They will receive either BMS-986253 alone or in combination with deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi).\n\nTreatment will be given in 28-day cycles. Participants will get BMS-986253 as an infusion on days 1 and 15 of each cycle. Some participants also will take oral DNMTi on days 2-6 of each cycle. They will receive treatment until their disease gets worse or they have bad side effects.\n\nAt study visits, some screening tests will be repeated. Some of the samples that are collected will be used for genetic testing.\n\nAbout 30 days after treatment ends, participants will have a follow-up visit to see how they are doing. After that, follow up will occur via phone every 3-6 months until the study ends.\n\nNational Institutes of Health (NIH) will cover the costs for some travel expenses....', 'detailedDescription': 'Background:\n\nThe myelodysplastic syndromes (MDS) are a group of clonal bone marrow neoplasms characterized by ineffective hematopoiesis, cytopenia, and high risk for transformation to acute myeloid leukemia (AML).\n\nMDS is primarily a disease of the elderly, with about 80% of participants being older than 65-years of age; with 10,000 new diagnoses per year in the United States (U.S.)\n\nThe only curative treatment for participants with MDS is allogeneic hematopoietic stem cell transplantation (HSCT) and only a small portion of participants are eligible. Depending on risk stratification, the median survival of high- and low-risk MDS participants is 1.5 to 5.9 years, respectively.\n\nDeoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) are the standard of care therapy for high-risk MDS. However, less than half of participants respond to DNMTi, and even the best responses are transient and non-curative. More effective and less toxic therapies are needed.\n\nInterleukin-8 (IL-8) is a proinflammatory chemokine from the chemokine (C-X-C motif) CXC family and a potent chemoattractant of granulocytes and related cells to the site of inflammation. IL-8 is uniquely upregulated and found at high levels in both the peripheral blood and bone marrow aspirates of MDS participants. In purified MDS/Acute myeloid leukemia (AML) long-term/short term stem cells and granulocyte-macrophage progenitor cells both IL-8 and the IL-8 receptor, CXCR2, are overexpressed.\n\nPreclinical data showed that CXCR2 inhibition led to significantly reduce proliferation of leukemic cell lines. In addition, MDS cluster of differentiation 34 (CD34+) cell cultures treated with neutralizing anti-IL-8 showed improvement in erythroid colony formation.\n\nBMS-986253 is a fully human Immunoglobulin G1 (IgG1) neutralizing antibody that showed a favorable safety profile in participants with advanced solid tumors.\n\nConcomitant treatment with DNMTi and BMS-986253 may improve treatment responses in participants with MDS by attenuating chemoattraction of myeloid derived suppressor cells to the bone marrow, indirectly disinhibiting natural killer (NK)- and T-cell responses against MDS stem cells, reducing neoangiogenesis, and improving cytopenia.\n\nObjectives:\n\nPrimary objectives:\n\nPhase I: To determine the optimal biological dose (OBD) and recommended phase 2 dose (RP2D) of BMS-986253 with or without DNMTi (decitabine and cedazuridine) therapy in MDS participants, and to describe the safety and tolerability of BMS-986253.\n\nPhase II: To determine overall response rate (ORR) to BMS-986253 with or without DNMTi (decitabine and cedazuridine) therapy in MDS, measured according to the proposed revised International Working Group (IWG) 2018 response criteria.\n\nEligibility:\n\nParticipants must have histologically or cytologically confirmed MDS according to 2016 World Health Organization (WHO) criteria and\n\n* have higher risk (HR) MDS Revised International Prognostic Scoring System (R-IPSS \\>= 3.5) and received a minimum of 2 and maximum of 8 cycles of DNMTi for Phase I (and a maximum of 4 cycles for Phase 2), or\n* have lower risk (LR) MDS (R-IPSS \\<3.5) and at least one cytopenia (for both Phases I and II).\n\nAge \\>=18 years\n\nEastern Cooperative Oncology Group (ECOG) performance status \\<=2 (KPS \\>= 60%)\n\nDesign:\n\nThis study consists of two phases:\n\nPhase I: safety evaluation with determination of optimal biological dose (OBD) of BMS-986253 with or without DNMTi (decitabine and cedazuridine), and\n\nPhase II: efficacy evaluation of BMS-986253 with or without DNMTi (decitabine and cedazuridine)\n\nIn both Phase I and II, participants will be enrolled into two cohorts:\n\nA) Higher-risk cohort (HR-MDS), including high-risk and higher intermediate-risk disease, defined as those with R-IPSS \\>= 3.5: treatment with BMS-986253 in combination with DNMTi (decitabine and cedazuridine)\n\nB) Lower-risk cohort (LR-MDS), including low-risk and lower intermediate-risk disease participants, defined as those with R-IPSS \\<3.5: treatment with BMS-986253 given as monotherapy\n\nFor Phase I, the safety endpoint will be dose limiting-toxicity (DLT) by D28 with the objective of defining the OBD and RP2D for BMS-986253. In addition, follow up for safety will be assessed 100 days after the end of the treatment cycle. For Phase II, the primary endpoint will be overall response rate after 6 cycles, reported separately by cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed myelodysplastic syndromes (MDS) according to 2016 World Health Organization (WHO) criteria\n* And:\n\n * have higher-risk myelodysplastic syndrome (HR-MDS) Revised International Prognostic Scoring System (R-IPSS \\>= 3.5) and received a minimum of 2 and maximum of 8 prior cycles for phase I and 4 for phase II of deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) therapy, or\n * have lower-risk myelodysplastic syndrome (LR-MDS) (R-IPSS \\<3.5),\n\n * and, at least one cytopenia:\n\n * granulocytes \\< 1.0 x 10\\^9/L and/or\n * hemoglobin \\< 110 g/L with signs/symptoms of symptomatic anemia or transfusion-dependency\n * platelets \\< 100 x 10\\^9/L\n* Age \\>=18 years\n\n --Because no dosing or adverse event data are currently available on the use of HuMax-interleukin 8 (IL-8) BMS-986253 as monotherapy or in combination with DNMTi in participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<=2 (Karnofsky \\>=60%).\n* Life expectancy greater than 6 months.\n* Participants must have adequate organ function as defined below:\n\n --total bilirubin \\<=1.5 X institutional upper limit of normal OR \\<=3 X institutional upper limit of normal in participants with Gilbert's syndrome (\\*except for participants with increased bilirubin levels attributed to intramedullary hemolysis, which will be allowable)\n* Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT)/Alanine transaminase (ALT)/Serum glutamic-pyruvic transaminase (SGPT) \\<=3 X institutional upper limit of normal OR \\<=5 X institutional upper limit of normal if related to disease specific cause\n* creatinine clearance (by Cockcroft-Gault) \\>=60 mL/min/1.73 m\\^2 for participants with creatinine levels above institutional normal.\n* The effects of BMS-986253 on the developing human fetus are unknown. For this reason and because DNMTi as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and up to 6 months after study completion and last dose of DNMTi.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* For phase I: Participants with HR-MDS (R-IPSS \\>=3.5) that have not yet received or received less than 2 cycles of DNMTi therapy.\n* Participants with LR-MDS (R-IPSS \\<3.5) with the following characteristics that have not yet received or are still deriving benefit from the following standard of care therapies:\n\n * Hemoglobin (Hgb) \\<10 g/dL, Epo level \\<500 mU/mL: Erythropoietin-stimulating agents (ESAs)\n * MDS with del5q: Lenalidomide\n * MDS with ringed sideroblasts (MDS-RS) with splicing factor 3b subunit 1 (SF3B1) mutation: Luspatercept\n* Participants with platelet transfusion-refractory thrombocytopenia, with inability to keep platelet threshold above 10K/mcL with transfusions or those with ongoing or uncontrolled hemorrhagic complications.\n* Participants with clinically significant neutropenia, absolute neutrophil count (ANC)\\<100, with frequent hospitalizations for infection (average \\>1 hospitalization per month in past 6 months)\n* Participants who are receiving or have received any other investigational agents within 28 days before start of study\n\ntreatment.\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DNMTi or other agents used in study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women or women presently breast-feeding their children are excluded due to unknown risks to a developing fetus or infant.\n* Any significant disease that, in the opinion of the investigator, may impair the participant s tolerance of study treatment.\n* Active or uncontrolled autoimmune diseases requiring treatment.\n* Chronic hepatitis B or C infection, because potential immune impairment caused by these disorders may diminish the effectiveness of this immunologic therapy.\n* Human immunodeficiency virus (HIV)-positive participants are ineligible because of the potential for decreased immune response.\n* Presence of any other malignancy (except basal and squamous cell carcinoma of the skin, or stable chronic cancers on hormone or targeted therapy) for which participant received systemic anticancer treatment within 24 months prior to enrollment.\n* Prior history of allogeneic hematopoietic stem cell transplantation."}, 'identificationModule': {'nctId': 'NCT05148234', 'briefTitle': 'BMS-986253 in Myelodysplastic Syndromes', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase I/II Trial of BMS-986253 in Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': '10000356'}, 'secondaryIdInfos': [{'id': '000356-C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.', 'interventionNames': ['Drug: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine', 'Drug: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine', 'Drug: BMS-986253', 'Procedure: Bone Marrow Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.', 'interventionNames': ['Drug: BMS-986253', 'Procedure: Bone Marrow Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.', 'interventionNames': ['Drug: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine', 'Drug: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine', 'Drug: BMS-986253', 'Procedure: Bone Marrow Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'description': 'Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.', 'interventionNames': ['Drug: BMS-986253', 'Procedure: Bone Marrow Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: ECG']}], 'interventions': [{'name': 'Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine', 'type': 'DRUG', 'description': 'For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants']}, {'name': 'Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine', 'type': 'DRUG', 'description': 'For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants']}, {'name': 'BMS-986253', 'type': 'DRUG', 'otherNames': ['Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253)'], 'description': 'Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants']}, {'name': 'Bone Marrow Biopsy', 'type': 'PROCEDURE', 'description': 'Bone marrow biopsy: required at screening/baseline, Phase I post cycle (C)\n\n1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants']}, {'name': 'Bone Marrow Aspiration', 'type': 'PROCEDURE', 'description': 'Bone marrow aspiration: required at screening/baseline, Phase I post cycle (C)\n\n1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants']}, {'name': 'ECG', 'type': 'PROCEDURE', 'otherNames': ['Electrocardiogram'], 'description': '12-lead electrocardiogram (ECGs) will be performed at baseline only for safety.', 'armGroupLabels': ['Phase I Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants', 'Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Najla El Jurdi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data from this study may be requested from other researchers after the completion of the primary endpoint. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.', 'ipdSharing': 'YES', 'description': 'All collected individual participant data (IPD) will be shared. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).', 'accessCriteria': 'Data from this study may be requested by contacting the principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Najla El Jurdi', 'investigatorAffiliation': 'National Cancer Institute (NCI)'}}}}