Venetoclax w/ Combination Chemotherapy

A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML

What's the purpose of the trial?

This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.
Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
116
Last Updated
1 month ago
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Experimental Treatments

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

  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Filgrastim is a bone marrow stimulant medication used to treat low white blood cell counts that are common side effects of cancer treatments. 
  • 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.
  • Pegfilgrastim is a medication given by subcutaneous injection to treat low white blood cells (neutropenia) caused by some cancer medicines.
  • 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. 

Arms / Cohorts

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Accepting patients

Venetoclax + Chemotherapy

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