EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

June 15, 2005

Primary Completion Date

August 11, 2016

Study Completion Date

August 11, 2022

Conditions
Lymphoma, Mantle CellMantle Cell Lymphoma
Interventions
DRUG

Rituximab (R)

Rituximab is given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and bortezomib every 3 weeks for 6 cycles.

BIOLOGICAL

EPOCH

EPOCH is given with Rituximab and bortezomib every 3 weeks for 6 cycles.

DRUG

Bortezomib (B)

Bortezomib is given alone for one cycle.

DRUG

Bortezomib

Bortezomib is given with EPOCH and rituximab every 6 weeks for 12 cycles.

DRUG

Bortezomib or observation

At the beginning of Part C, patients are randomized to receive bortezomib maintenance or be observed w/o bortezomib.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00114738 - EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter