Clinical trial · Observational
Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML
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
NCT06580106CI-TRIAL-00119245recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. * Age ≥ 18 years of age at the time of consent * Confirmed diagnosis of AML * Planned initial treatment with azacitidine and venetoclax * Ability to read and understand the English and/or Spanish language * As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.