Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

NCT00355407 | Completed

• 1 other identifier: 05-420
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Keywords

Aranesp; allogeneic stem cell transplant

Outcome Measures

Primary Outcomes (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 Outcomes (2)

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

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

Interventions

Darbepoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hematologic malignancies undergoing ablative allogeneic stem cell transplantation for any indication
• 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

Sponsors & Collaborators

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

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Eric Jacobsen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 21, 2006
• Study Start: June 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 13, 2009

Record last verified: 2009-03

Locations

US (1)