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
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Soluble beta-glucan (SBG)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biotec Pharmacon ASA:

Estimated Enrollment: 12
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533728

Locations
Norway
Rikshospitalet, Kreftklinikken Radiumhospitalet
Oslo, Norway, 0310
Sponsors and Collaborators
Biotec Pharmacon ASA
Investigators
Principal Investigator: Gustav Lehne, MD, PhD Oslo University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00533728     History of Changes
Other Study ID Numbers: SBG-2-02
Study First Received: September 20, 2007
Last Updated: March 2, 2009
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014