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CompletedNCT00533728Updated Mar 4, 2009

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

A Phase 1 interventional study of Soluble beta-glucan (SBG) in Non-Hodgkin's Lymphoma, sponsored by Biotec Pharmacon ASA. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-04.

Sponsored by Biotec Pharmacon ASA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Hodgkin's Lymphoma
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 12 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Biotec Pharmacon ASA is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • DrugSoluble beta-glucan (SBG)
06

Study locations

1 site
  • Rikshospitalet, Kreftklinikken Radiumhospitalet
    Oslo, 0310, Norway
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00533728
Lead sponsor
Biotec Pharmacon ASA
First posted
Sep 21, 2007
Start date
Sep 2007
Primary completion
Feb 2009
Completion
Mar 2009
Last update
Mar 4, 2009

Study contacts

Gustav Lehne, MD, PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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