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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Soluble beta-glucan (SBG)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No