NCT00533728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

September 20, 2007

Last Update Submit

March 2, 2009

Conditions

Non-Hodgkin's Lymphoma

Interventions

Soluble beta-glucan (SBG)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, Kreftklinikken Radiumhospitalet

Oslo, 0310, Norway

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Gustav Lehne, MD, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 21, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

NO(1)