Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2026-02-06 @ 2:28 AM
Study NCT ID:
NCT06580106
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2024-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity side effect', 'timeFrame': 'From initiation of venetoclax through 30 days after last dose', 'description': 'Defined as a binary variable indicating whether a participant experienced a Grade 3 or higher of specific side effects (including infections, anemia, thrombocytopenia, febrile neutropenia, neutropenia, nausea, diarrhea)'}], 'secondaryOutcomes': [{'measure': 'Dose Modification', 'timeFrame': 'Approximately 6 months or until last dose of Venetoclax, whichever came first', 'description': 'A binary variable indicating whether a participant experienced a dose modification, including delay or reduction'}, {'measure': 'Disease Response', 'timeFrame': 'Up to 3 years', 'description': 'For participants diagnosed with AML, response will be defined as a binary variable indicating if they had a Complete Remission (CR), Complete Remission with partial hematologic recovery (CRh), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free state (MLFS), or partial response (PR) to induction therapy using the European LeukemiaNet (ELN 2022) criteria. Otherwise they will be considered a non-responder'}, {'measure': 'Venetoclax levels', 'timeFrame': 'Approx 6 months', 'description': 'Will be defined as the maximum concentration of Venetoclax and is measured at 6 months if the participant is still receiving venetoclax'}, {'measure': 'Overall survival', 'timeFrame': 'Approx 3 years', 'description': 'Duration of time from date of enrollment to death. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive'}, {'measure': 'Dose modification due to nausea or diarrhea', 'timeFrame': 'Approximately 6 months or until last dose of Venetoclax, whichever came first', 'description': 'A binary variable indicating whether a participant experienced a dose modification, including delay or reduction due to nausea or diarrhea'}, {'measure': 'Metabolizer status checklist', 'timeFrame': 'Approximately 6 months or until last dose of Venetoclax, whichever came first', 'description': 'A categorical variable indicating whether a participant is a high, normal or low metabolizer based on pharmacogenomics analysis of SNP data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.', 'detailedDescription': 'This is a prospective pilot study of the association of SNPs and venetoclax levels with toxicity and response to azacitidine plus venetoclax (Aza/Ven) as well as pharmacogenomics and venetoclax levels in patients with newly diagnosed AML determined to be unfit for intensive induction. Newly diagnosed AML patients over 18 years old who receive Aza/Ven as standard of care will be eligible for this study. Buccal swabs for SNPs and pharmacogenomic analysis can occur at any point before or after starting treatment during the study period. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. Participants will be recruited initially at AHWFBCCC locations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with AML who are receiving or are planned to receive azacitidine plus venetoclax will be identified in clinic and presented informed consent for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information.\n* Age ≥ 18 years of age at the time of enrollment\n* Confirmed diagnosis of AML\n* Planned initial treatment with azacitidine and venetoclax\n* Ability to read and understand the English and/or Spanish language\n* As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06580106', 'briefTitle': 'Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Prospective Pilot Study of the Genetic Determinants of Toxicity and Response to Azacitidine and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Through Evaluation of Polymorphisms in Pharmacokinetic Genes and Venetoclax Levels', 'orgStudyIdInfo': {'id': 'IRB00116209'}, 'secondaryIdInfos': [{'id': 'LCI-LEU-AML-VENTOX-001', 'type': 'OTHER', 'domain': 'Atrium Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'AML participants who are receiving or are planned to receive azacitidine plus venetoclax', 'description': 'Buccal swabs for SNPs and pharmacogenomic analysis can occur at any point before or after starting treatment during the study period. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. CYP3A activity will also be evaluated. Demographic and cancer related history will be acquired for each participant. During study participation, cancer treatment details including administration, dose modifications, delays, and reductions, including specific grade 3 toxicities, stem cell transplant status, symptom burden, disease response, and survival will be collected. Participants will be taken off study after three years.', 'interventionNames': ['Other: Biospecimen samples']}], 'interventions': [{'name': 'Biospecimen samples', 'type': 'OTHER', 'description': 'Buccal swabs and Blood samples will be collected throughout study.', 'armGroupLabels': ['AML participants who are receiving or are planned to receive azacitidine plus venetoclax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Courtney Schepel', 'role': 'CONTACT', 'email': 'courtney.schepel@advocatehealth.org', 'phone': '(980) 292-0817'}, {'name': 'Brittany Ragon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy Pardee, MD', 'role': 'CONTACT', 'email': 'tspardee@wakehealth.edu', 'phone': '336-716-2466'}, {'name': 'Timothy Pardee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Courtney Schepel', 'role': 'CONTACT', 'email': 'courtney.schepel@advocatehealth.org', 'phone': '(980) 292-0817'}], 'overallOfficials': [{'name': 'Brittany Ragon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atrium Health Wake Forest Baptist Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Health Levine Cancer Institute', 'class': 'OTHER'}, {'name': 'Swim Across America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}