A Phase 2 Study Comparing Daunorubicin/Cytarabine, Daunorubicin/Cytarabine/Venetoclax, and Venetoclax/Azacitidine in Young Adults With Intermediate-Risk Acute Myeloid Leukemia

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Full Title

A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients with Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial (MM1YA-CTG01) (CIRB)

Purpose

For people with newly diagnosed acute myeloid leukemia (AML), the more leukemia cells are destroyed, the better their long-term outcomes. In this study, researchers want to see adding venetoclax to standard chemotherapy (daunorubicin/cytarabine) or giving it with azacitidine works better than standard therapy for getting rid of the small amount of remaining leukemia cells. The people in this study include young adults with intermediate-risk AML.

Venetoclax is in a class of medications called BCL-2 inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein cancer cells need to survive.

If you join this study, you will get one of these regimens of treatment:

  • Daunorubicin, cytarabine, and venetoclax
  • Azacitidine and venetoclax
  • Daunorubicin and cytarabine

Who Can Join

To join this study, there are a few conditions. You must:

  • Be age 18-59.
  • Have newly diagnosed AML with features indicating an intermediate risk of it coming back after treatment.
  • You may join this study even if you have leukemia in the brain and spinal space.

Contact

For more information or to see if you can join this study, please call 888-874-5087. We can help answer any questions and connect you (or your patient) with the study team.

Protocol

25-087

Phase

Phase II (phase 2)

Investigator

Co-Investigators