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

This study has been completed.
Sponsor:
Information provided by:
Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:
NCT00533728
First received: September 20, 2007
Last updated: March 2, 2009
Last verified: March 2009

September 20, 2007
March 2, 2009
September 2007
February 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00533728 on ClinicalTrials.gov Archive Site
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Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: Soluble beta-glucan (SBG)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00533728
SBG-2-02
No
Not Provided
Biotec Pharmacon ASA
Not Provided
Principal Investigator: Gustav Lehne, MD, PhD Oslo University Hospital
Biotec Pharmacon ASA
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP