Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

NCT ID: NCT00355407

Last Updated: 2009-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-08-31

Brief 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.

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.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Darbepoetin alfa

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Eric Jacobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

05-420

Identifier Type: -

Identifier Source: org_study_id