Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

March 12, 2009 updated by: Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital
Amgen

Investigators

  • Principal Investigator: Eric Jacobsen, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 13, 2009

Last Update Submitted That Met QC Criteria

March 12, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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