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|
- Maximum Tolerated Dose (MTD) of Eltrombopag [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]The MTD was defined as the highest dose if no dose limiting toxicity was observed, or the highest dose at which less than one-third of the patients experienced toxicities not expected in the standard stem cell transplantation setting.
- Median Time to Platelet Engraftment [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]Determined for all participants who completed at least 75% of the planned doses. Platelet engraftment was as defined by the Center for International Blood and Marrow Transplant Research as the first of 3 consecutive days of a platelet count 20,000/mL without platelet trans-fusions for 7 days and/or the first day of a platelet count 100,000/mL without platelet transfusions for 7 days.
- Median Number of Platelet Transfusions up to the Day of Engraftment [ Time Frame: baseline to day of engraftment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||December 2015|
|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|