Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma
Number of Subjects: During the Phase 1 part of the study as many as 15 subjects may be
enrolled, based on the dose escalation scheme; the actual number of subjects enrolled will
depend on the dose level at which the maximum tolerated dose (MTD) is established.
During the Phase 2 part of the study, approximately 15 subjects will be enrolled in order to
obtain a total 30 response-evaluable subjects.
Study Objectives:
The primary objectives of this study are:
• Assess the CR and ORR following treatment with VELCADE (bortezomib), Nipent (pentostatin)
and Rituxan (rituximab) (VNR) in subjects with follicular lymphoma (FL), marginal zone
lymphoma (MZL), and mantle cell lymphoma (MCL) who have relapsed or been refractory after
receiving at least 1 prior therapy.
The secondary objectives of this study are to:
- Determine the MTD of VELCADE and Nipent in combination with Rituxan (VNR) in subjects
with follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma
(MCL) who have relapsed or been refractory after receiving at least 1 prior therapy
- Evaluate the safety and tolerability of VNR
- Determine the time to response
- Determine duration of response
- Determine the time to progression (TTP)
- Determine the progression free survival (PFS) rate
- Determine the 1-year survival
- Determine overall survival (OS)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CR following treatment with VELCADE(bortezomib)/Nipent(pentostatin/Rituxan (rituximab)(VNR) in subjects with follicular lymphoma(FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)relapsed or refractory after at least 1 prior therapy
Study Days 1, 4, 8, 11 of 6 cycles (up to 3 weeks each) and Days 63/126, then Study Months 6, 9, 12, 15, 18, 21, 24, 30, 36, 42 and 48
up to 48 months
No
Francesco Turturro, MD
Principal Investigator
LSUHSC-S
United States: Institutional Review Board
X05266
NCT01460602
May 2010
October 2014
Name | Location |
---|---|
LSU - Shreveport Health Sciences Center, Feist-Weiller Cancer Center | Shreveport, Louisiana 71103 |