A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
18 Years
N/A
Both
Hematologic Malignancies
Trial Information
A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
- 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 three weeks for a maximum of four doses.
- Blood tests will be performed at weeks 3, 6, 9 and 12. The blood tests done at week
three will check to make sure the participant has enough iron in their system. If not,
they will need to take an iron supplement. Participants will also take a folate
supplement to help cell growth and reproduction.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.
Principal Investigator
Eric Jacobsen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
05-420
NCT ID:
NCT00355407
Start Date:
June 2006
Completion Date:
August 2007
Related Keywords:
- Hematologic Malignancies
- Aranesp
- allogeneic stem cell transplant
- Neoplasms
- Hematologic Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
