Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematologic Malignancies
Intervention: Darbepoetin alfa (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s): Eric Jacobsen, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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 blood cell levels without blood transfusions.
Clinical Details
Official title: A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.
Secondary outcome: Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantationrecord transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Additional Information
Starting date: June 2006
Last updated: March 12, 2009
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