Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma
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
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:
Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months
for the first year post treatment, then every 6 months until disease progression or death for
years 2 through 5 post treatment. Patients who have disease progression will be contacted
every 6 months until death to assess for survival status.
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