Clinical Trial PRECOGHEM0901
Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia (AML) in Complete Remission
- Protocol No. PRECOGHEM0901
- Open Date: 12/04/2012
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy.
- Disease Sites: Leukemia
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Cytarabine (ARA-C); Eltrombopag
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01656252
- Secondary Protocol No: PrE0901
Patients are invited to take part in this study if: - they have Acute Myeloid Leukemia (AML), and - they will be receiving high-dose consolidation chemotherapy with cytarabine, and - [Phase I study patients only] their AML in first or second complete remission, or - [Phase II study patients only] their AML is in first complete remission only. The purpose of this study is to find out if the study drug, eltrombopag, will help raise platelet count while patients are receiving high-dose cytarabine chemotherapy. High-dose cytarabine causes low blood counts (white blood cells, red blood cells, and platelets) for days or weeks. This may result in hospitalization, treatment with antibiotics, and transfusions with blood and/or platelets. As a result, chemotherapy doses could be lowered or treatment could be delayed. High-dose cytarabine is approved by the Food and Drug Administration (FDA) for the treatment of AML. Eltrombopag is a drug that received FDA approval for the treatment of chronic ITP (idiopathic thrombocytopenic purpura). Chronic ITP is a bleeding condition due to a low number of platelets. Eltrombopag may also help raise the number of platelets during chemotherapy and may help prevent the risk of bleeding. Eltrombopag is a tablet that is taken by mouth. Eltrombopag is in a class of medicines called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to make more platelets. Eltrombopag has not been approved for use in AML and it is being tested in research studies (considered investigational). This study is being done to find out the highest safe and tolerated dose of eltrombopag while patients are receiving high dose cytarabine chemotherapy.