Back to resultsDarbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Primary Purpose
Hematologic Malignancies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Aranesp, allogeneic stem cell transplant
Eligibility 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
Sites / Locations
- Dana-Farber Cancer Institute
Outcomes
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.
Full Information
NCT ID
NCT00355407
First Posted
July 19, 2006
Last Updated
March 12, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Amgen, Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00355407
Brief Title
Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Official Title
A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Amgen, Brigham and Women's Hospital
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Aranesp, allogeneic stem cell transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation
Title
record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Jacobsen, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation
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