Phase I Study of Eltrombopag for Promoting Thrombopoiesis After Total Body Irradiation
Patients who undergo total body irradiation (TBI) for stem cell transplantation have prolonged periods of low counts of specific blood cells called platelets. These low platelets counts can cause bleeding and infection. Thus far, no drug is available for use to speed the recovery of platelets, and therefore transfusions are often necessary.
The purpose of this study is to test the safety of a drug called eltrombopag in patients who have received TBI. The investigators want to find out what effects, good or bad, it has on people with low platelet counts due to treatment with TBI. The investigators will also be testing how well eltrombopag may work at different doses and determine if this drug speeds up the recovery of the platelets.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Eltrombopag for Promoting Thrombopoiesis in Patients Undergoing Stem Cell Transplantation After Total Body Irradiation|
- to determine the safety, side effect profile, and toxicity of eltrombopag when administered to patients undergoing stem cell transplantation from autologous or allogeneic donor sources, who have received myeloablative doses of TBI [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
- to collect preliminary efficacy data for accelerating the recovery of megakaryopoiesis and meaningful platelet production by eltrombopag [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903929
|Study Director:||Yuhchyau Chen, MD,PhD||University of Rochester|
|Principal Investigator:||Jane Liesveld, MD||University of Rochester|