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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gustav Lehne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

SBG-2-02

NCT ID:

NCT00533728

Start Date:

September 2007

Completion Date:

March 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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