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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533728
• Other study ID #: SBG-2-02
• 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

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

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,