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
National Cancer Institute (NCI)
Summary
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.
Description
PRIMARY OBJECTIVE: I. To compare measurable residual disease (MRD) negative complete remission (CR) rates between each of the experimental regimens and cytarabine + daunorubicin (7+3). SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities with each of the regimens. II. 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. III. To describe and compare MRD negative CR ra…
Eligibility
- Age range
- 18–59 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * STEP 1 REGISTRATION: * Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study. * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria * Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criter…
Interventions
- DrugAzacitidine
Given SC or IV
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- DrugCytarabine
Given IV
- DrugDaunorubicin Hydrochloride
Given IV
- ProcedureEchocardiography Test
Undergo ECHO
- DrugLiposome-encapsulated Daunorubicin-Cytarabine
Locations (221)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Alta Bates Summit Medical Center-Herrick CampusBerkeley, California