A Measurable Residual Disease (MRD) Driven, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Not open
Phase: II (Cancer Control)
Principal Investigator: Haddadin, Michael
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05554393?term=NCT05554393&rank=1#participation-criteria
Summary
1.1 Primary Objective
To compare the rates of undetectable measurable residual disease (MRD) in patients who achieve a Complete Remission (CR) after induction therapy with 7 +3 (cytarabine + daunorubicin) vs. azacitidine + venetoclax vs. 7+3 + venetoclax.
1.2 Secondary Objectives
To estimate the frequency and severity of toxicities with each of the regimens.
To estimate complete remission (CR) rates (with and without MRD), complete remission with incomplete count recovery (CRi) (with and without MRD) rates, event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) with each of the regimens.
1.3 Tertiary Objectives
To evaluate response to therapy received according to genomic findings
To evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and beyond.
To evaluate longer term outcomes by treatment arm, genomics, MRD outcome, and other features as patients receive additional myeloMATCH therapies to generate testable hypotheses for more precise patient selection for these therapies