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Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00355407
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : March 13, 2009
Information provided by:

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
Hematologic Malignancies Drug: Darbepoetin alfa

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  (Clinical Trial)
Estimated Enrollment : 31 participants
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 : June 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355407

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Eric Jacobsen, MD Dana-Farber Cancer Institute
More Information

ClinicalTrials.gov Identifier: NCT00355407     History of Changes
Other Study ID Numbers: 05-420
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by Dana-Farber Cancer Institute:
allogeneic stem cell transplant

Additional relevant MeSH terms:
Darbepoetin alfa