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R-CyBor-D in Relapsed Low Grade and Mantle Cell Lymphoma
NCT00711828Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2008
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules, Modified Peptides
- Drugs
- bortezomib
- Conditions
- follicular lymphoma (FL)mantle cell lymphoma (MCL)Waldenstrom macroglobulinemia (WM)marginal zone lymphoma (MZL)small lymphocytic lymphoma (SLL)
01
Overview
Phase 2, open-label, single-arm trial of bortezomib in follicular lymphoma (FL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM) and 3 more, sponsored by Mayo Clinic. Primary endpoint: Proportion of Responses (Complete Response or Partial Response). Started Aug 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment (R-CYBOR-D)
Patients receive rituximab, cyclophosphamide, bortezomib, and dexamethasone.
03
Who it enrols
Patients with relapsed or refractory follicular (Gr 1 or 2), mantle cell, marginal zone, SLL/CLL, or Waldenstrom's macroglobulinemia. Must have measurable disease and adequate organ function.
04
Endpoints
Primary
Proportion of Responses (Complete Response or Partial Response)
Secondary
Overall Survival
Progression-free Survival
Duration of Response
Time to Treatment Failure
Adverse Event Profile
Quality of Life for Patient Reported Neurotoxicity
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