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Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma

Sponsor
Biotec Pharmacon ASA (Industry)
Overall Status
Completed
CT.gov ID
NCT00533728
Collaborator
(none)
12
Enrollment
1
Location
18
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Soluble beta-glucan (SBG)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study to Determine the Safety and Effect of Soluble Beta-Glucan (SBG) in Combination With Rituximab and COP/CHOP in Patients With Non'Hodgkin's Lymphoma
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. CD20 positive B-cell non-Hodgkin's lymphoma

    2. Treatment with rituximab and CHOP or COP

    3. Performance status 0 or 1 according to the WHO scale (Appendix)

    4. Expected lifetime of more than 12 weeks

    5. Age ≥ 18 years

    6. The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained

    Exclusion Criteria:

    1. Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy test must be provided during the screening test. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation

    2. Lymphoma involvement of central nervous system

    3. Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l, neutrophil counts < 1.5 x 109/l, thrombocyte counts < 100 x 109/l or hemoglobin < 10 g/dl

    4. Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN

    5. Reduced renal function defined by serum creatinine ≥ 2 x ULN

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rikshospitalet, Kreftklinikken Radiumhospitalet Oslo Norway 0310

    Sponsors and Collaborators

    • Biotec Pharmacon ASA

    Investigators

    • Principal Investigator: Gustav Lehne, MD, PhD, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00533728
    Other Study ID Numbers:
    • SBG-2-02
    First Posted:
    Sep 21, 2007
    Last Update Posted:
    Mar 4, 2009
    Last Verified:
    Mar 1, 2009
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of Mar 4, 2009