Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT) - Full Text View

Purpose

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

Condition	Intervention	Phase
Hematological Malignancies	Drug: Darbepoetin alpha (Aranesp) Drug: Iron saccharate (Venofer)	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Darbepoetin-alpha and i.v. Iron Administration After Autologous Hematopoietic Stem Cell Transplantation : a Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Iron

Drug Information available for: Erythropoietin Epoetin Alfa Darbepoetin Alfa

U.S. FDA Resources

Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:

Median time to achieve hemoglobin (Hb) level > 13 g/dL in each arm. [ Time Frame: 126 days after hematocrit (HCT) ] [ Designated as safety issue: No ]
Proportion of complete correctors (i.e. patients reaching Hb > 13 g/dL) before day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Median time to increase Hb level by > 2 g/dL in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Proportion of responders (i.e. patients increasing Hb by > 2 g/dL) before day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Proportion of correctors (i.e. patients reaching Hb > 12 g/dL) before day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Proportion of patients requiring red blood cell transfusions between day 28 and day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Total number of red blood cell transfusions between day 28 and day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Area under the curve of mean Hb level between day 28 and day 126 after the transplant in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Mean Hb values on days 42, 56, 70, 84, 98, 112, and 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]
Mean change in Quality Of Life (QOL) measurements between day 28 and day 126 in each arm. [ Time Frame: 126 days after HCT ] [ Designated as safety issue: No ]

Enrollment:	125
Study Start Date:	March 2004
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 No medication given
Active Comparator: 2 Aranesp 300 µg/15 days	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. Other Name: Aranesp
Active Comparator: 3 Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant.	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. Other Name: Aranesp 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. Other Name: Venofer

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557817

Locations

Belgium
Vrije Universiteit Brussel
Brussels, Belgium, 1050
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
CHU Sart Tilman
Liege, Belgium, 4000
CHR la citadelle
Liege, Belgium, 4000

Sponsors and Collaborators

University Hospital of Liege

Amgen

Katholieke Universiteit Leuven

Vrije Universiteit Brussel

Investigators

Study Chair:	Yves Beguin, MD, PhD	CHU-ULg
Principal Investigator:	Frederic Baron, MD, PhD	CHU-ULg
Principal Investigator:	Johan Maertens, MD, PhD	Katholieke Universiteit Leuven
Principal Investigator:	Rik Schots, MD	Vrije Universiteit Brussel
Principal Investigator:	Bernard DePrijck, MD	CHR Citadelle

More Information

No publications provided

Responsible Party:	Beguin Yves, University Hospital of liege
ClinicalTrials.gov Identifier:	NCT00557817 History of Changes
Other Study ID Numbers:	TJE0301
Study First Received:	November 13, 2007
Last Updated:	January 8, 2010
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital of Liege:

HCT
autologous
erythropoiesis

iron saccharate
erythropoietin
darbepoetin alpha

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Ferric oxide, saccharated
Darbepoetin alfa
Epoetin Alfa
Ferric Compounds
Iron

Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013