Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355407
• Other study ID #: 05-420
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: March 12, 2009
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: March 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancies

Intervention

Drug:
• Darbepoetin alfa

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Amgen, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.
Secondary	Evaluate the percentage of patients achieving a greater than 1 g/dL hemoglobin increase between days 30 and 100 after allogeneic stem cell transplantation
Secondary	record transfusion requirements between days 30 and 100 in patients undergoing darbepoetin alfa administration following allogeneic stem cell transplantation.