Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
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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.
Condition or disease
Drug: Darbepoetin alfa
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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