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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00533728
Other study ID # SBG-2-02
Secondary ID
Status Completed
Phase Phase 1
First received September 20, 2007
Last updated March 2, 2009
Start date September 2007
Est. completion date March 2009

Study information

Verified date March 2009
Source Biotec Pharmacon ASA
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Soluble beta-glucan (SBG)


Locations

Country Name City State
Norway Rikshospitalet, Kreftklinikken Radiumhospitalet Oslo

Sponsors (1)

Lead Sponsor Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

Norway, 

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