A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

October 23, 2018

Study Completion Date

October 7, 2020

Conditions
Lymphoma, Follicular
Interventions
DRUG

Atezolizumab (MPDL3280A) [TECENTRIQ]

Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.

DRUG

Lenalidomide

Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.

DRUG

Obinutuzumab

Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.

Trial Locations (16)

10065

Memorial Sloan-Kettering Cancer Center; Hematology/Oncology, New York

21034

Hopital du Bocage, Dijon

28204

Levine Cancer Institute, Charlotte

33136

University Miami, Miami

34295

CHU Montpellier - Saint ELOI, Montpellier

35033

CHU de Rennes - Hopital de Pontchaillo, Rennes

35294

University of Alabama at Birmingham, Birmingham

40207

Norton Medical Plaza II, Louisville

44093

CHU - Hôtel Dieu hematolgie clinique, Nantes

59037

CHRU de Lille - Hopital Claude Huriez, Lille

69495

Centre Hospitalier Lyon Sud; Hematolgie, Pierre-Bénite

69500

Chu Toulouse, Bron

72015

Centre Jean Bernard, Le Mans

72037

Centre Hospitalier Le Mans, Le Mans

76038

Centre Henri Becquerel, Rouen

94010

Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny, Créteil

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02631577 - A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma | Biotech Hunter | Biotech Hunter