Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

December 31, 2009

Study Completion Date

April 7, 2011

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

PEPC

"Induction phase (month 1-3)~• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC \< 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.~Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~• PEPC QOD or fractionated weekly basis"

DRUG

Thalidomide

"Induction phase (month 1-3)~• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.~Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~• Daily low dose thalidomide (50-100mg/d)"

DRUG

Rituximab

"Induction phase (month 1-3)~• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.~Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.~Post-Month 12 Maintenance phase (post-month 12 until disease progression)~• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months"

Trial Locations (1)

10021

Weill Medical College of Cornell University, New York

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER

NCT00151281 - Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter