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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00533728
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 4, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00533728     History of Changes
Other Study ID Numbers: SBG-2-02
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: March 2009

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