Trial Information
A Two-stage Phase III, International, Multi-center, Randomized, Controlled, Open-label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Inclusion Criteria:
- Adult patients, >/=18 years of age
- CD20-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must
have been performed within 6 months before study entry with material available for
central review.
- No prior treatment
- ECOG performance status 0-2
Exclusion Criteria:
- Grade 3b follicular lymphoma
- Transformation to high-grade lymphoma secondary to follicular lymphoma
- Types of Non-Hodgkin's lymphoma other than follicular lymphoma
- Presence or history of CNS disease
- Corticoid therapy during the last 4 weeks, except prednisone treatment <20 mg per day
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Stage I: To estimate the ratio of trough serum concentrations of MabThera after subcutaneous administration to that obtained after intravenous administration
Outcome Time Frame:
Day 21
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
To: be added
Study ID:
BO22334
NCT ID:
NCT01200758
Start Date:
February 2011
Completion Date:
April 2019
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin