Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Completed · Not applicable

Conditions studied: Hematologic Malignancies

In brief

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.

Key facts

Study ID

NCT00355407

Run by

Dana-Farber Cancer Institute

People needed

31

Starts

2006-06-01

Expected to finish

2007-08-01

Last updated by the study team

2009-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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