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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Hematological Malignancies
Interventions
DRUG

Darbepoetin alpha (Aranesp)

Darbepoetin alpha (Aranesp) will be administered subcutaneously (s.c.) at the dose of 300 µg. The first dose will be given on day 28 and the following doses at 2-week intervals around days 42, 56, 70, 84, 98 and 112 post-transplant. Once the target Hb (13 g/dL) has been attained, the dose of Aranesp will be reduced by half to 150 µg. If the Hb increases to \> 14 g/dL, Aranesp will be withheld and resumed at the dose of 150 µg when the Hb decreases \< 13 g/dL. If the Hb decreases to \< 12 g/dL, the dose of Aranesp will be increased to 300 µg again.

DRUG

Iron saccharate (Venofer)

Iron saccharate (Venofer) will be administered intravenously (i.v.) at the dose of 200 mg (2 vials of Venofer) on days 28, 42 and 56 after the transplant. Venofer will be diluted in 250 ml saline and infused over 60 minutes. Iron will be omitted in patients with severe iron overload (serum ferritin \> 2500 µg/L in the absence of inflammation or liver necrosis) or elevated transferrin saturation (TS \> 60%) between days 21 and 56. No iron supplementation will be allowed in arm 1. No iron supplementation will be allowed in arm 2 before day 70 after the transplant. In arms 2 and 3, if patients have evidence of functional iron deficiency (transferrin saturation \< 20%) on day 70 or later, they will receive 300 mg of Venofer over 90 min, for a minimum of 2 doses.

Trial Locations (4)

1050

Vrije Universiteit Brussel, Brussels

3000

Katholieke Universiteit Leuven, Leuven

4000

CHR la citadelle, Liège

CHU Sart Tilman, Liège

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

KU Leuven

OTHER

collaborator

Vrije Universiteit Brussel

OTHER

lead

University of Liege

OTHER