A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,030

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2017

Study Completion Date

April 30, 2024

Conditions
Follicular Lymphoma
Interventions
DRUG

Rituximab

• Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

DRUG

Lenalidomide

• Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3\~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles

DRUG

Rituximab - CHOP

six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles

DRUG

Rituximab - CVP

eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,

DRUG

Rituximab - Bendamustine

six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Trial Locations (35)

Unknown

Concord Repatriation General Hospital, Concord

Nepean Hospital, Penrith

Wollongong Hospital, Wollongong

CHU Mont-Godinne, Yvoir

Tom Baker Cancer Centre, Calgary

Cross Cancer Institute, Edmonton

Fraser Valley Cancer Centre, Surrey

BCCA - Vancouver Cancer Centre, Vancouver

Moncton Hospital, Moncton

Atlantic Health Sciences Corp - Saint John Regional Hospital, Halifax

Sunnybrook Health Sciences Centre, Toronto

UHN-Princess Margaret Hospital, Toronto

CHUM Hopital Notre-Dame, Montreal

McGill University Department of Oncology, Montreal

Hôpital de l'Enfant-Jesus, CHU de Quebec, Québec

Saskatoon Cancer Centre, Saskatoon

CHU Claude Huriez, Lille

Medizinische Klinik der Universität Tübingen, Tübingen

Uniklinik Köln, Cologne

LMU Munchën - Klinikum Grosshadern, München

Sant'Andrea Hospital, Rome

Policlinico Sant'Orsola-Malpighi, Bologna

Instituto Português Oncologia, Lisbon

Hospital Virgen del Rocio, Seville

Hospital Universitario Mutua de Terrassa, Terrassa

Hospital Universitario de Canarias, Santa Cruz de Tenerife

Hospital Son Llatzer, Palma

Hospital Clínico de Barcelona, Barcelona

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Universitario Vall d´Hebron, Barcelona

Institut Català d'Oncologia de Girona (ICO Girona), Girona

Hospital Ramon y Cajal, Madrid

Hospital Costa del Sol, Marbella

Hospital Universitario Salamanca, Salamanca

Hospital Clínico Universitario de Valencia, Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

The Lymphoma Academic Research Organisation

OTHER