Status:
COMPLETED
Eltrombopag for Post Transplant Thrombocytopenia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this dr...
Detailed Description
The Study Drug: Platelets are cells that help the blood clot. Platelet counts are often lower after receiving a stem cell transplant. When the number of platelets in your body gets too low, it can ca...
Eligibility Criteria
Inclusion
- Patients \>/= 35 days post HCT with Platelet count \</= 20 x 10\^9/l sustained for 7 days or patients are platelet transfusion dependent, and
- Neutrophil count \>/= 1.5 x 10\^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and
- Age \>/= 18
Exclusion
- Recurrence or progression of primary malignancy after HCT
- ALT \>/= 2.5 times the ULN
- Serum bilirubin \>2mg/dl (unless due to Gilbert's syndrome)
- Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.
- ECOG Performance status \>2
- Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization. A negative pregnancy test result will be required before any study drug is given.
Key Trial Info
Start Date :
February 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01000051
Start Date
February 17 2010
End Date
April 4 2018
Last Update
September 18 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030