Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma

Summary

Clinical Hypothesis:

It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects.

Conditions

• Malignant Lymphoma

Interventions

DRUG

r-metHuSCF and Filgrastim

Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.

DRUG

r-metHuSCF and Filgrastim

Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.

DRUG

Chemotherapy plus Filgrastim

Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.

Sponsors & Collaborators

• Herlev Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• University Hospital, Linkoeping

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Nordic Lymphoma Group

  collaborator NETWORK

• Amgen

  collaborator INDUSTRY

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Hans E Johnsen, MD DMSc · Aalborg Hospital and Herlev University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-01-31

Primary Completion

2000-11-30

Completion

2009-11-30

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations