A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT00634179
Protocol IDs
IRB# 29960007 (primary)
Study Sponsor
Winship Cancer Institute of Emory University

Summary

This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Objectives

This study will assess whether adding Velcade to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.

Patients who are eligible to take part in the study will initially receive VR-CHOP with an increase in the dose of Velcade and then the dose of vincristine to determine the safe doses for these drugs in combination. Then, patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects.