MyeloMATCH MM1YA-S01 (Acute Myeloid Leukemia)

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

Who Can Participate?

Eligibility

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 Range

18-59

Sex/Genders

Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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

Harry
Erba

Protocol Number

PRO00116098

NCT ID

NCT05554406

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov