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OpenTrials
Completed

NCT Number: NCT00533728

Safety of Soluble Beta-Glucan (SBG) in Treatment of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rikshospitalet, Kreftklinikken Radiumhospitalet

Oslo, 0310, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soluble beta-glucan (SBG)

Drug

Sponsors and collaborators

Lead sponsor

Biotec Pharmacon ASA

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2007
Registry last updated
Mar 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.