Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

April 30, 2010

Study Completion Date

April 24, 2013

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Bortezomib, CHOP, Rituximab

"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 (Bortezomib) 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"

Trial Locations (4)

10021

Weill Medical College of Cornell University, New York

10032

Columbia University College of Physicians and Surgeons, New York

68198

Nebraska Medical Center, Omaha

02115

Dana Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER