Study of Bortezomib in Combination With Cyclophosphamide and Rituximab

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Mantle Cell LymphomaLymphoma
Interventions
DRUG

Bortezomib

Bortezomib 1.3 mg/m\^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.

DRUG

Rituximab

375 mg/m\^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.

DRUG

Cyclophosphamide

300 mg/m\^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle

DRUG

Mesna

600 mg/m\^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.

DRUG

G-CSF

5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER