Status:
COMPLETED
Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Amgen
Brigham and Women's Hospital
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to help raise red...
Detailed Description
* Participants will receive Darbepoetin alfa through an injection under the skin, about 28-35 days after their allogeneic stem cell transplant. They will continue to receive the study drug once every ...
Eligibility Criteria
Inclusion
- Hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication
- 18 years of age or older
- Hgb of less than 10 g/dL at the time of initiation therapy
Exclusion
- Known hypersensitivity reaction to darbepoetin alfa or any of its components
- Transfusion of packed red blood cells within 3 days of initiation of treatment with darbepoetin alfa
- Any history of grade III or IV GVHD
- Use of any erythropoietic growth factor since transplantation
- Uncontrolled hypertension
- History of seizure
- Baseline creatinine greater than 2
- Dialysis dependence at the time of enrollment
- Hemolytic uremic syndrome
- Active GI bleeding
- Concurrent autoimmune hemolytic anemia
- Concurrent unstable angina
- History of congenital hypercoagulable state or previous venous or arterial thrombosis
- Relapsed disease prior to the initiation of study treatment
- History of renal cell carcinoma
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00355407
Start Date
June 1 2006
End Date
August 1 2007
Last Update
March 13 2009
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115