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

Biotec Pharmacon

Status and phase: Completed; Phase 1

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Soluble beta-glucan (SBG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533728

SBG-2-02

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)