Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-24-106-C-MM1YA-SO1
Prinicipal Investigator
Cioccio, Joseph
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
MM1YA-S01
Title
A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial
Objective
Primary Objectives:
To compare measurable residual disease (MRD) negative complete remission (CR) rates between each of the experimental regimens and Cytarabine + Daunorubicin (7+3).

Secondary Objective(s):
To estimate the frequency and severity of toxicities with each of the regimens. To estimate complete remission (CR) rates, complete remission with incomplete count recovery (CRi, with and without MRD) rates, event-free survival (EFS), time to relapse, relapse-free survival (RFS), and overall survival (OS) with each of the regimens. To describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms.
Applicable Disease Sites
Myeloid and Monocytic Leukemia
Status
Open
Participating Institutions
Hershey Medical Center