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

NCT01016795 | Terminated Phase 2

• 2 other identifiers: SCF 980266H-KA-99040-GMS
• Study Type: interventional
• Target: 32
• Locations: 4 countries
• Sites: 8

Brief 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

Keywords

SCF; Priming; Mobilization; Lymphoma; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Safety and Toxicity was assessed by morbidity, including unexpected adverse events associated with the priming and the transplantation phases during study, and measured and graded by CTC criteria.

  From inclusion to 1 months post transplantation

Secondary Outcomes (1)

• To compare the time dependent level of blood circulating and harvested haematopoietic stem cells and progenitors (PBSC) in patients treated with either a combination of r-metHuSCF and Filgrastim, or conventional chemotherapy plus Filgrastim.

  From inclusion to 1 months post transplantation

Study Arms (2)

r-metHuSCF and Filgrastim

ACTIVE COMPARATOR

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; Drug: Chemotherapy plus Filgrastim

Cyclophosphamide and Filgrastim

ACTIVE COMPARATOR

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; Drug: Chemotherapy plus Filgrastim

Interventions

r-metHuSCF and Filgrastim DRUG

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.

Also known as: Stem Cell Factor and G-CSF

Cyclophosphamide and Filgrastim; r-metHuSCF and Filgrastim

Chemotherapy plus Filgrastim DRUG

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.

Also known as: Priming chemotherapy and G-CSF

Cyclophosphamide and Filgrastim; r-metHuSCF and Filgrastim

Eligibility Criteria

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

You may qualify if:

• Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification)
• in relapse
• refractory to initial chemotherapy
• with partial response after initial therapy
• Age \> 18 years and \< 65 years
• ECOG performance status 0, 1 or 2
• Life expectancy of \> 6 months with treatment
• ANC \> or equal to 1.5 x 109/L, Platelets \> or equal to 100 x 109/L
• Serum creatinine \< or equal to 150 µmol/L, bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) less than twice the upper limit defined at the investigating laboratory
• Prior to mobilization chemotherapy subject has given written informed consent, personally dated

You may not qualify if:

• Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant
• Any history of seasonal or recurrent asthma within the preceding 10 years.
• Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded
• Any history of angioedema or recurrent urticaria
• Clinical or microbiological evidence of infection at the date of enrollment.
• Subjects with a concurrent malignancy
• Significant non-malignant disease including documented HIV infection, uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled atrial or ventricular cardiac arrhythmias
• Pregnant or breast feeding subjects or those of child-bearing potential who are not using adequate contraceptive precautions
• Concurrent enrollment on any other protocol using an investigational drug
• Haematopoietic growth factors administered within one week of study entry
• Subjects with a psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
• Known sensitivity to E. coli derived products
• Concurrent use of beta adrenergic blocking agents

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Umeå University: collaborator
• Oslo University Hospital: collaborator
• Nordic Lymphoma Group: collaborator
• Amgen: collaborator

Study Sites (8)

Aalborg Hospital

Aalborg, 9000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev University Hospital

Copenhagen, Denmark

Location

University Hospital Helsinki

Helsinki, Finland

Location

University Hospital Turku

Turku, Finland

Location

Radiumhospitalet

Oslo, Norway

Location

University Hospital Linköping

Linköping, Sweden

Location

University Hospital Umeå

Umeå, Sweden

Location

MeSH Terms

Conditions

Lymphoma

Interventions

ancestim; Filgrastim; Stem Cell Factor; Granulocyte Colony-Stimulating Factor; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics

Study Officials

• Hans E Johnsen, MD DMSc

  Aalborg Hospital and Herlev University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 20, 2009
• Study Start: January 1, 1999
• Primary Completion: November 1, 2000
• Study Completion: November 1, 2009
• Last Updated: June 25, 2015

Record last verified: 2009-11

Locations

SE (2); DK (3); FI (2); NO (1)