Last updated on December 2018

Eltrombopag in Cord Blood or Haploidentical Bone Marrow Transplantation

Brief description of study

The goal of this clinical research study is to learn if taking Promacta (eltrombopag) will help your platelet count improve faster after your stem cell transplant. The safety of this drug will also be studied.

This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Its use in patients with low platelet counts after a stem cell transplant is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

Study Drug Administration:

If you agree to take part in this study, you will take eltrombopag by mouth 1 time each day for up to 60 days. The study drug should be taken on an empty stomach (1 hour before or 2 hours after food/drink). You may drink water, coffee, and/or tea with the study drug. Do not use any milk or cream in your coffee or tea. If you vomit the drug within 30 minutes of taking, the dose should be repeated.

If you will have a cord blood transplant, you will start taking eltrombopag 1 day before your transplant (Day -1).

If you will have (or have had) a haploidentical transplant, you will start taking eltrombopag 5 days after your transplant (Day +5).

Study Visits:

You will be admitted to the hospital as part of your transplant and during your stay blood will be drawn daily as standard transplant care to check your blood counts, kidney and liver functions. Once you are discharged, you will be seen as an outpatient 1-3 times per week as standard post-transplant care.

Blood (about 1 tablespoon) will be drawn once a week while you are taking eltrombopag, and then once a week for 4 weeks after the last dose of eltrombopag to check your blood counts, kidney, and liver function.

About 1, 2, 3, 6, and 12 months after your transplant, blood (about 5 tablespoons) will be drawn to check your immune system.

If you have a blood and/or platelet transfusion, research staff will record the number of transfusions you receive during the study.

Length of Study:

You will be on study for about 1 year. You will be taken off study early if your platelet count becomes too high, if you have any intolerable side effects, if you are unable to follow study directions, if your doctor thinks it is in your best interest, or if you choose to leave the study early.

Clinical Study Identifier: NCT01927731

Contact Investigators or Research Sites near you

Start Over

Uday Popat, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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