Overview
Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT)
Status:
Completed
Completed
Trial end date:
2008-08-01
2008-08-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital of Liege
University of LiegeCollaborators:
Amgen
Katholieke Universiteit Leuven
KU Leuven
Vrije Universiteit BrusselTreatments:
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)