Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-04-04 @ 12:24 PM
Study NCT ID:
NCT06536959
Status:
RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C000707970', 'term': 'tislelizumab'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'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': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'timeFrame': 'At the end of Cycle 2 (each cycle is 28 days)', 'description': 'percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)'}, {'measure': 'Complete minimal residual disease (MRD) Response Rate', 'timeFrame': 'At the end of Cycle 2 (each cycle is 28 days)', 'description': 'Percentage of subjects with MRD negative or MRD \\< 0.01%'}, {'measure': 'MRD Response Rate', 'timeFrame': 'At the end of Cycle 2 (each cycle is 28 days)', 'description': 'Percentage of subjects with MRD \\< 0.1% detectable by multicolor flow cytometry'}], 'secondaryOutcomes': [{'measure': 'Relapse-Free Survival', 'timeFrame': '24 months', 'description': 'Time interval from leukemia free state to the first recurrence or death'}, {'measure': 'Overall Survival', 'timeFrame': '24 months', 'description': 'Time interval from start of treatment until death or last follow-up'}, {'measure': 'Duration of response', 'timeFrame': '24 months', 'description': 'Time interval from morphologic/MRD response to loss of response or death'}, {'measure': 'Adverse events', 'timeFrame': 'start of treatment to 2 weeks after end of treatment', 'description': 'Number of subjects with adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venetoclax', 'Hypomethylation agen', 'PD-1 inhibitor'], 'conditions': ['Relapsed Acute Myeloid Leukemia', 'Refractory Acute Myeloid Leukemia', 'Myelodysplastic Syndromes', 'Minimal Residual Disease']}, 'descriptionModule': {'briefSummary': 'The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.\n* Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.\n* Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.\n* The toxic and side effects caused by the last treatment should be recovered.\n* Eastern Cooperative Oncology Group score of 0 to 3 points.\n* The organ function is intact.\n\n * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).\n * Creatinine≤2×ULN.\n * Bilirubin≤2×ULN.\n* Karnofsky≥70.\n* The expected survival period is at least 12 weeks.\n* Non-pregnant, non-breastfeeding women.\n\nExclusion Criteria:\n\n* Suffering from other untreated or unrelieved malignant tumors within 2 years.\n* Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.\n* Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \\[NYHA\\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.\n* Patients who are unwilling or unable to comply with the protocol.\n* Currently being treated with other systemic anti-tumor or anti-tumor research drugs.\n* Women who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06536959', 'briefTitle': 'VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS', 'orgStudyIdInfo': {'id': 'VA-PD1-MN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VA-PD1i', 'description': 'Patients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine.', 'interventionNames': ['Drug: PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine']}], 'interventions': [{'name': 'PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine', 'type': 'DRUG', 'otherNames': ['PD-1 inhibitor (Tislelizumab)', 'Venetoclax (ABT-199, GDC-0199)', 'Decitabine (Dacogen, 5-aza-2-deoxycytidine)', 'Azacitidine (5-Azacytidine, Ladakamycin)'], 'description': 'For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.\n\nFor MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician.\n\nThe venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors).', 'armGroupLabels': ['VA-PD1i']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-ning Gao', 'role': 'CONTACT', 'email': 'gaoxn@263.net', 'phone': '86-010-66947169'}, {'name': 'Lei Xu', 'role': 'CONTACT', 'email': 'xulei800@hotmail.com', 'phone': '86-010-66947174'}], 'facility': 'Xiao-ning Gao', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Xiao-Ning Gao', 'investigatorAffiliation': 'Beijing 302 Hospital'}}}}