Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of Liege; University of Liege
• Collaborators: Amgen; Katholieke Universiteit Leuven; KU Leuven; Vrije Universiteit Brussel
• Treatments: Darbepoetin alfa; Epoetin Alfa; Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion criteria:

• Male or female; female patients must use a reliable contraception method

• Age > 16 yrs and < 70 yrs

• No terminal organ failure

• Written informed consent given by patient or his/her guardian if of minor age.

• Adequate iron stores (serum ferritin > 100 µg/L) on day 21 post-transplant.

• Adequate marrow recovery, as shown by: neutrophils > 1,000/µL, platelet transfusion independence

• PBSC (not marrow) transplantation

Exclusion criteria:

• HIV positive

• Known allergy to recombinant human erythropoietin or i.v. iron saccharate

• Evidence of active hemorrhage, hemolysis, vitamin B12 or folate deficiency on day 28 post-transplant (inclusion into the protocol may then be delayed up until day 42 if the problem is resolved)

• Uncontrolled infection, arrythmia or hypertension on day 28 post-transplant (inclusion into the protocol may then be delayed up until day 42 if the problem is resolved)

• Evidence of severe iron overload (transferrin saturation > 60%, serum ferritin > 2500 µg/L on day 21 post-transplant)