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Velcade, Nipent, Rituxan (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:
Phase 1/2 Study of VELCADE (Bortezomib), Nipent (Pentostatin), and Rituxan (Rituximab) (VNR) in Subjects With Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma

Clinical Trial Summary

This is a phase 1/2 Study of VELCADE (bortezomib), Nipent (pentostatin), and Rituxan (rituximab) (VNR) in Subjects with Relapsed Follicular, Marginal Zone, and Mantle Cell Lymphoma.

Clinical Trial Description

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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01460602
Study type Interventional
Source Louisiana State University Health Sciences Center Shreveport
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date May 2010
Completion date October 2014
View Details
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