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MCL Elderly: R-CHOP vs R-FC and Rituximab Maintenance
NCT00209209Phase 3
Key facts
- Status
- Unknown
- Start
- Jan 2004
- Primary completion
- Dec 2018
- Countries
- 7
- Sponsor
- European Mantle Cell Lymphoma Network
- Modality
- Monoclonal Antibodies
- Drugs
- rituximab
- Conditions
- mantle cell lymphoma (MCL)
01
Overview
Phase 3, randomised, open-label trial of rituximab in mantle cell lymphoma (MCL) (4 arms), sponsored by European Mantle Cell Lymphoma Network. Primary endpoints: Complete Remission Rate and Progression-Free Survival. Status: unknown.
02
Design
4 arms- Study design
- RandomizedOpen-label
R-CHOP -> Rituximab
R-CHOP induction followed by Rituximab maintenance
R-CHOP -> IFN
R-CHOP induction followed by Interferon maintenance
R-FC -> Rituximab
R-FC induction followed by Rituximab maintenance
R-FC -> IFN
R-FC induction followed by Interferon maintenance
03
Who it enrols
Elderly patients (>=65 years, or 60-65 if unfit for high-dose therapy) with previously untreated stage II-IV mantle cell lymphoma.
04
Endpoints
Primary
Complete Remission Rate
Progression-Free Survival
Secondary
Overall Survival
Time to Treatment Failure
Side Effects of Therapy
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