Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help increase the number of platelets during chemotherapy and may help prevent the risk of bleeding. Phase I will study the side effects, best dose and platelet effects of eltrombopag when given with consolidation chemotherapy. After the maximum safe and tolerated dose and schedule is found in Phase I, the study will proceed to Phase II. Phase II will confirm the dose and schedule of eltrombopag identified in Phase I that can increase platelet counts in patients receiving consolidation therapy.

Key facts

Study ID

NCT01656252

Run by

PrECOG, LLC.

People needed

15

Starts

2012-07-01

Expected to finish

2016-03-01

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytomorphologically documented diagnosis of acute myeloid leukemia (AML). Acute promyelocytic leukemia patients will be excluded (FAB M3). FAB classification, cytogenetics and molecular markers (if applicable) must be available at registration.
• Phase I Enrollment:
• Must be in first or second complete remission, e.g., no evidence of active disease in blood, bone marrow (<5% blasts), or other tissues.
• For each remission, may have received no more than 2 cycles of induction treatment (any type).
• May have received no more than one course of consolidation for the current remission prior to enrollment (any type)
• Phase II Enrollment:
• Must be in first complete remission, e.g., no evidence of active disease in blood, bone marrow (<5% blasts), or other tissues.
• May have received no more than 2 cycles of induction treatment (any type).
• Enrollment in Either Phase:
• Remission status must be documented by a bone marrow examination up to 28 days prior to study registration.
• Have recovered from induction and first consolidation (if applicable) therapy side effects (or ≤grade 1).
• ≥18 years of age and ≤70 years of age.
• ECOG performance status 0, 1, 2.
• Have not received cytotoxic drug therapy within 21 days of registration.
• Have not received hematopoietic colony stimulating growth factors within 14 days of registration.
• Have not received packed red blood cells or platelets within 7 days of registration.
• Have not received investigational agents within 30 days of registration and will not receive any investigational agents other than eltrombopag/placebo during study.
• Signed IRB-approved informed consent.
• Willing to provide blood samples for research purposes.
• Adequate organ function obtained within 28 days prior to registration:
• Absolute neutrophil count >1 x 10⁹/L
• Platelet count >100 x 10⁹/L
• Total direct serum bilirubin ≤1.5x upper limit of normal (ULN)
• ALT and AST ≤3x ULN
• BUN and serum creatinine <2x ULN

Where it is running

• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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