MyeloMATCH MM1OA-EA02 (Acute Myeloid Leukemia)

Purpose of this Study

We are doing this study to compare the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib. We want to find out if adding gilteritinib to the usual treatment is beneficial for people with acute myeloid leukemia (AML).

Who Can Participate?

Eligibility

Adults ages 60+ who:
  • Are diagnosed with AML
  • Have not received previous treatment for AML with some exceptions (exceptions = hydroxyurea, all-trans retinoic acid, leukapheresis, and cytarabine-based emergency therapy)
  • Have an FLT3-ITD or D835 mutation
Patients who are younger than 60 years old can be considered if their treating physician believes that an azanucleoside-based therapy rather than intensive, cytarabine-based treatment is more likely to be favorable for them. For more information about this study, contact the study team at nick.jeffries@duke.edu.

Age Range

18-110

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 (like drawing straws) to 1 of 3 groups:
  • Group One: If you are in this group, you will get the drugs azacitidine and venetoclax. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax as tablets that you take by mouth. You will take these drugs for defined time periods called "cycles" and be assessed at the end of each cycle. Each cycle lasts 28 days. There will be a maximum of 24 cycles.
  • Group Two: If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.
  • Group Three: If you are in this group, you will get the drugs azacitidine, venetoclax, and gilteritinib. You will receive azacitidine by injection into a vein in your arm or subcutaneously (under the skin). You will get venetoclax and gilteritinib as tablets that you take by mouth. Each cycle lasts 28 days. There will be a maximum of 24 cycles.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

Study Details

Full Title

MyeloMATCH MM1OA-EA02, A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial (NCT06317649)

Principal Investigator

Harry
Erba

Protocol Number

PRO00116258

NCT ID

NCT06317649

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov