Ivosidenib and Combination Chemotherapy

Phase 1 Trial of Ivosidenib and FLAG Chemotherapy in Relapsed/Refractory IDH1+ Acute Myeloid Leukemia (AML)

What's the purpose of the trial?

This phase I trial studies the side effects and best dose of ivosidenib when given together with combination chemotherapy for the treatment of 1DH1 mutant acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Ivosidenib may stop the growth of cancer cells by blocking the IDH1 mutation and some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and filgrastim, 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. Giving ivosidenib with combination chemotherapy may work better in treating patients with acute myeloid leukemia compared to chemotherapy alone.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
25
Last Updated
2 months ago
Am I Eligible

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.

  • 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.
  • Ivosidenib is a small molecule inhibitor that is approved for use in acute myeloid leukemia and cholangiocarcinoma.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Treatment (combination chemotherapy, ivosidenib)

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