Skip to main content
OpenTrials
Completed

NCT Number: NCT00355407

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

Primary outcomes

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

Secondary outcomes

  1. Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation

  2. record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Amgen
  • Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 21, 2006
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.