Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
Status:
Completed
Trial end date:
2013-04-24
Target enrollment:
Participant gender:
Summary
Primary Objective:
To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when
administered in combination with CHOP + Rituximab to patients with previously untreated
diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)
Secondary Objectives:
To assess the response rate (overall and complete), event-free survival and overall survival
with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle
cell lymphoma (phase II component)
Treatment:
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of
VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0)
0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4