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R-GCVP for DLBCL unsuitable for R-CHOP
NCT00971763Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2006
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- University College London
- Modality
- Small Molecules
- Drugs
- gemcitabine
- Conditions
- diffuse large B-cell lymphoma (DLBCL)
01
Overview
Phase 2, open-label, single-arm trial of gemcitabine in diffuse large B-cell lymphoma (DLBCL), sponsored by University College London. Primary endpoint: Overall Response Rate. Started Mar 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
R-GCVP
Rituximab, Gemcitabine, Cyclophosphamide, Vincristine, Prednisolone
03
Who it enrols
Newly diagnosed CD20+ DLBCL patients with bulky stage IA-IV disease who are not eligible for R-CHOP due to impaired cardiac function (LVEF < 50% or NYHA III-IV).
04
Endpoints
Primary
Overall Response Rate
Secondary
Toxicity
Progression-Free Survival
Overall Survival
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