A Phase I/II Study of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia in Complete Remission

Protocol
12-229
Full Title
Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia (AML) in Complete Remission (PrECOG; PRE0901)
Purpose

Patients with acute myeloid leukemia (AML) who achieve a complete remission (no evidence of cancer cells) may receive high doses of a drug called cytarabine as part of “consolidation therapy” to reduce their risk of the cancer returning. During this treatment, however, patients’ blood cell counts fall very low. Some patients may need to be hospitalized. Low blood cell counts may also make it necessary for doctors to delay chemotherapy or reduce the patient’s dose, decreasing the effectiveness of therapy.

Eltrombopag is a drug approved for treating a disease that causes low platelet counts (the blood cells needed for clotting). In this study, researchers are evaluating the highest dose of eltrombopag that can be given with cytarabine in patients receiving consolidation therapy for AML that is in complete remission. Once the optimal dose is identified, investigators will assess the effectiveness of adding eltrombopag to cytarabine therapy to see if it can boost platelet counts and shorten the period of time during consolidation therapy when platelet counts are low. Eltrombopag is taken orally (by mouth).

Investigator
Martin S. Tallman, MD -- Chief, Leukemia Service
Martin S. Tallman - Physician Profile
Co-Investigators
Jae Park, MD
Jae Park - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have AML in first or second complete remission.
  • Patients may not have received more than one prior regimen of consolidation therapy for the current remission.
  • At least 3 weeks must have passed since completion of prior chemotherapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Disease(s)
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations
Related Diseases

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