Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Amgen; Brigham and Women's Hospital
• Treatments: Darbepoetin alfa

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