Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,030

Participants

Timeline

Start Date

December 29, 2011

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
Follicular Lymphoma
Interventions
DRUG

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

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

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

DRUG

Rituximab-CVP

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

DRUG

Rituximab-Bendamustine

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Trial Locations (36)

10019

Local Institution - 52403, New York

10021

Local Institution - 50203, New York

21157

Local Institution - 53603, Westminster

23230

Local Institution - 53303, Richmond

32806

Local Institution - 51703, Orlando

33705

Local Institution - 53803, St. Petersburg

34223

Local Institution - 52503, Englewood

37203

Local Institution - 51303, Nashville

40536

Local Institution - 52203, Lexington

48075

Local Institution - 53003, Southfield

60657

Local Institution - 50803, Chicago

63110

Local Institution - 51003, St Louis

75246

Local Institution - 51203, Dallas

77030

Local Institution - 51103, Houston

79410

Local Institution - 54003, Lubbock

80909

Local Institution - 51603, Colorado Springs

85224

Local Institution - 54103, Chandler

90095

Local Institution - 52003, Los Angeles

92835

Local Institution - 51803, Fullerton

98109

Local Institution - 52703, Seattle

1358550

Local Institution - 40222, Koto-ku

7200001

Local Institution - 40422, Hiroshima

02114

Local Institution - 50403, Boston

Local Institution - 50503, Boston

08003

Local Institution - 54403, Cherry Hill

07601

Local Institution - 53703, Hackensack

07960

Local Institution - 50903, Morristown

07871

Local Institution - 54303, Sparta

104-0045

Local Institution - 40722, Chuo-ku

105-8470

Local Institution - 41122, Minato-ku

812-8582

Local Institution - 40922, Fukuoka

259-1193

Local Institution - 40122, Isehara City, Kanagawa

650-0047

Local Institution - 40322, Kobe

602-8566

Local Institution - 40622, Kyoto

983-8520

Local Institution - 41022, Sendai

410-2295

Local Institution - 40522, Shizuoka

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The Lymphoma Academic Research Organisation

OTHER

lead

Celgene

INDUSTRY

NCT01476787 - Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma | Biotech Hunter | Biotech Hunter