Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
Sponsors
Biotec Pharmacon ASA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
Norway
Outcome results
None listed