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

NCT00557817 | Completed Phase 2

• 1 other identifier: TJE0301
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Hematological Malignancies

Keywords

HCT; autologous; erythropoiesis; iron saccharate; erythropoietin; darbepoetin alpha

Outcome Measures

Primary Outcomes (2)

• Median time to achieve hemoglobin (Hb) level > 13 g/dL in each arm.

  126 days after hematocrit (HCT)

• Proportion of complete correctors (i.e. patients reaching Hb > 13 g/dL) before day 126 in each arm.

  126 days after HCT

Secondary Outcomes (8)

• Median time to increase Hb level by > 2 g/dL in each arm.

  126 days after HCT

• Proportion of responders (i.e. patients increasing Hb by > 2 g/dL) before day 126 in each arm.

  126 days after HCT

• Proportion of correctors (i.e. patients reaching Hb > 12 g/dL) before day 126 in each arm.

  126 days after HCT

• Proportion of patients requiring red blood cell transfusions between day 28 and day 126 in each arm.

  126 days after HCT

• Total number of red blood cell transfusions between day 28 and day 126 in each arm.

  126 days after HCT

Study Arms (3)

1

NO INTERVENTION

No medication given

2

ACTIVE COMPARATOR

Aranesp 300 µg/15 days

Drug: Darbepoetin alpha (Aranesp)

3

ACTIVE COMPARATOR

Aranesp 300 µg/15 days. Venofer 200 mg on days 28, 42, and 56 after the transplant.

Drug: Darbepoetin alpha (Aranesp); Drug: Iron saccharate (Venofer)

Interventions

Darbepoetin alpha (Aranesp) DRUG

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.

Also known as: Aranesp

2; 3

Iron saccharate (Venofer) DRUG

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.

Also known as: Venofer

3

Eligibility Criteria

• Age: 16 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HIV positive
• Known allergy to recombinant human erythropoietin or i.v. iron saccharate
• Evidence of severe iron overload (transferrin saturation \> 60%, serum ferritin \> 2500 µg/L on day 21 post-transplant)

Sponsors & Collaborators

• University of Liege: lead
• Amgen: collaborator
• KU Leuven: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (4)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1050, Belgium

Location

Katholieke Universiteit Leuven

Leuven, Leuven, 3000, Belgium

Location

CHR la citadelle

Liège, Liege, 4000, Belgium

Location

CHU Sart Tilman

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Darbepoetin alfa; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Yves Beguin, MD, PhD

  CHU-ULg

  STUDY CHAIR

• Frederic Baron, MD, PhD

  CHU-ULg

  PRINCIPAL INVESTIGATOR

• Johan Maertens, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Rik Schots, MD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

• Bernard DePrijck, MD

  CHR Citadelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: March 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 11, 2010

Record last verified: 2008-08

Locations

BE (4)