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VR-CHOP in Untreated Indolent NHL
NCT00634179Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- Nov 2015
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules, Modified Peptides
- Drugs
- bortezomib
- Conditions
- follicular lymphoma (FL)small lymphocytic lymphoma (SLL)marginal zone lymphoma (MZL)
01
Overview
Phase 2, open-label, single-arm trial of bortezomib in follicular lymphoma (FL), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL), sponsored by Emory University. Primary endpoint: Maximal Tolerated Doses of Bortezomib and Vincristine up to 24 weeks. Started Feb 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment (VR-CHOP regimen)
Bortezomib + R-CHOP induction followed by Rituximab (+/- Bortezomib) maintenance
03
Who it enrols
Previously untreated CD20+ B-cell non-Hodgkin lymphoma (Follicular, SLL, MZL) requiring treatment based on GELF or FLIPI criteria. Adequate organ function required.
04
Endpoints
Primary
Maximal Tolerated Doses of Bortezomib and Vincristine
Secondary
Overall Response Rate
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