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

Tracking Information

First Received Date ^ICMJE

July 19, 2006

Last Updated Date

March 12, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00355407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Official Title ^ICMJE

A Pilot Study of Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Hematologic Malignancies

Intervention ^ICMJE

Drug: Darbepoetin alfa

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00355407

Responsible Party

Study ID Numbers ^ICMJE

05-420

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Amgen
Brigham and Women's Hospital

Investigators ^ICMJE

Principal Investigator:

Eric Jacobsen, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP