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Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborators:
Amgen
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00355407
First received: July 19, 2006
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention
Hematologic Malignancies
 Drug: Darbepoetin alfa

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 31
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355407

Locations
United States, Massachusetts
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00355407     History of Changes
Other Study ID Numbers: 05-420
Study First Received: July 19, 2006
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Darbepoetin alfa
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013