Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Soluble beta-glucan (SBG)
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- CD20 positive B-cell non-Hodgkin's lymphoma
- Treatment with rituximab and CHOP or COP
- Performance status 0 or 1 according to the WHO scale (Appendix)
- Expected lifetime of more than 12 weeks
- Age ≥ 18 years
- The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained
Exclusion Criteria:
- 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
- Lymphoma involvement of central nervous system
- 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
- Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
- Reduced renal function defined by serum creatinine ≥ 2 x ULN
Sites / Locations
- Rikshospitalet, Kreftklinikken Radiumhospitalet
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00533728
Brief Title
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biotec Pharmacon ASA
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Soluble beta-glucan (SBG)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CD20 positive B-cell non-Hodgkin's lymphoma
Treatment with rituximab and CHOP or COP
Performance status 0 or 1 according to the WHO scale (Appendix)
Expected lifetime of more than 12 weeks
Age ≥ 18 years
The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained
Exclusion Criteria:
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
Lymphoma involvement of central nervous system
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
Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
Reduced renal function defined by serum creatinine ≥ 2 x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Lehne, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet, Kreftklinikken Radiumhospitalet
City
Oslo
ZIP/Postal Code
0310
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
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