Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00355407
• Collaborator: Amgen (Industry), Brigham and Women's Hospital (Other)
• Enrollment: 31
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: Darbepoetin alfa	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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 Measures

1. Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation []

2. record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• Amgen
• Brigham and Women's Hospital

Investigators

• Principal Investigator: Eric Jacobsen, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00355407
• Other Study ID Numbers: 05-420
• First Posted: Jul 21, 2006
• Last Update Posted: Mar 13, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Aranesp; allogeneic stem cell transplant
• Additional relevant MeSH terms: Hematologic Neoplasms; Darbepoetin alfa

Study Results

No Results Posted as of Mar 13, 2009