Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

December 31, 2011

Study Completion Date

May 31, 2014

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Bendamustine

Bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

DRUG

Rituximab

Patients receive 375 mg/m\^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

Trial Locations (13)

Unknown

Teva Investigational Site 11, Fountain Valley

Teva Investigational Site 2, Los Angeles

Teva Investigational Site 35, Orlando

Teva Investigational Site 30, Lafayette

Teva Investigational Site 20, Bethesda

Teva Investigational Site 4, Hackensack

Teva Investigational Site 3, Buffalo

Teva Investigational Site 43, Gettysburg

Teva Investigational Site 33, Bryan

Teva Investigational Site 41, Grapevine

Teva Investigational Site 23, Lynchburg

Teva Investigational Site 6, Ottawa

Teva Investigational Site 7, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT00891839 - Bendamustine Hydrochloride in Combination With Rituximab in Patients With Relapsed Refractory Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter