Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Amgen Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00355407

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:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Darbepoetin alfa

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

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

Keywords provided by Dana-Farber Cancer Institute:

Aranesp
allogeneic stem cell transplant

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Hematinics
Hematologic Diseases

Therapeutic Uses
Hematologic Agents
Darbepoetin alfa
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009