Status:
COMPLETED
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously un...
Eligibility Criteria
Inclusion
- Cluster of differentiation 20 (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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion
- 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 central nervous system (CNS) disease
- Corticoid therapy during the last 4 weeks, except prednisone treatment less than (\<) 20 milligrams per day (mg per day)
- Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
Key Trial Info
Start Date :
February 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT01200758
Start Date
February 15 2011
End Date
October 31 2017
Last Update
November 27 2018
Active Locations (152)
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1
Gosford Hospital; Cancer Care Services
Gosford, New South Wales, Australia, 2250
2
Wollongong Hospital; Cancer Services
Wollongong, New South Wales, Australia, 2500
3
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
4
Gold Coast Hospital; Haematology Department
Southport, Queensland, Australia, 4215