MyeloMATCH MM1YA-S01 (Acute Myeloid Leukemia)

What is the Purpose of this Study?

We are doing this study to compare different experimental drug regimens to the usual treatment (cytarabine and daunorubicin) for acute myeloid leukemia (AML). We want to find out which options have the best outcomes. The different drug combinations we will be testing against the usual treatment are:

  • daunorubicin and cytarabine liposome
  • cytarabine and daunorubicin with venetoclax
  • azacitidine and venetoclax
  • daunorubicin and cytarabine liposome with venetoclax
What is the Condition Being Studied?

Acute Myeloid Leukemia (AML)

Who Can Participate in the Study?

Adults ages 18-59 who:

  • Are newly diagnosed with AML that is classified as high-risk (adverse) per ELN 2017 criteria
  • Have not started treatment yet for AML
  • Do not have acute promyelocytic leukemia
  • Do not have favorable or intermediate risk disease
  • Do not have any FLT3 mutations

For more information about this study, please contact the study team at marty.c.cauley@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 5 groups:

  • Group 1: If you are in this group, you will get the usual drugs used to treat this type of cancer (cytarabine and daunorubicin).
  • Group 2: If you are in this group, you will get the usual treatment drugs (cytarabine and daunorubicin) plus venetoclax.
  • Group 3: If you are in this group, you will get azacitidine and venetoclax.
  • Group 4: If you are in this group, you will get daunorubicin and cytarabine liposome.
  • Group 5: If you are in this group, you will get daunorubicin, cytarabine liposome, and venetoclax.

Study Details

Full Title
MyeloMATCH MM1YA-S01: 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
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00116098
NCT: NCT05554406
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF