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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 20, 2007

Last Updated Date

March 2, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00533728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: Soluble beta-glucan (SBG)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CD20 positive B-cell non-Hodgkin's lymphoma
Treatment with rituximab and CHOP or COP
Performance status 0 or 1 according to the WHO scale (Appendix)
Expected lifetime of more than 12 weeks
Age ≥ 18 years
The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained

Exclusion Criteria:

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
Lymphoma involvement of central nervous system
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
Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
Reduced renal function defined by serum creatinine ≥ 2 x ULN

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00533728

Other Study ID Numbers ^ICMJE

SBG-2-02

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Biotec Pharmacon ASA

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gustav Lehne, MD, PhD

Oslo University Hospital

Information Provided By

Biotec Pharmacon ASA

Verification Date

March 2009

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

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