Venetoclax with Induction & Consolidation

A Phase II Randomized Clinical Trial of Venetoclax Combined With FLAG IDA Induction and Consolidation Compared to Standard of Care for Newly Diagnosed Patients With Acute Myeloid Leukemia

What's the purpose of the trial?

This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
102
Last Updated

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Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Idarubicin is an anti-neoplastic chemotherapy drug used to treat several different kinds of cancers.
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 
  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Daunorubicin is an anti-neoplastic chemotherapy drug used to treat several different types of cancer.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Arm 1: Fludarabine, Cytarabine, Idarubicin, Venetoclax

Accepting patients

Arm 2: Cytarabine, Daunorubicin

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