A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 27, 2015

Primary Completion Date

July 7, 2020

Study Completion Date

July 7, 2020

Conditions
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
DRUG

CC-122

CC-122 will be administered daily starting at Cycle 1 Day 1 in 28-day cycles until disease progression, unacceptable toxicity, or discontinuation for any other reason.

DRUG

Ibrutinib

DRUG

Obinutuzumab

Obinutuzumab will be administered as an intravenous (IV) infusion at a dose of 100 mg on Cycle 1 Day 1 and 900 mg on Cycle 1 Day 2 and 1000 mg on Cycle 1 Days 8 and 15. The dose of obinutuzumab on Days 1 and 2 of Cycle 1 may be adjusted per institutional practice as long as the combined dose equals 1000 mg. Obinutuzumab will be administered at a dose of 1000 mg on Day 1 of Cycles 2 through 6.

Trial Locations (24)

1090

Allgemeines Krankenhaus Wien, Vienna

5020

University Hospital of Salzburg St Johanns Spital, Salzburg

6020

University Hospital Innsbruck, Innsbruck

10065

Weill Cornell Medical College Dr. Feldman's Office, New York

20089

Istituto Clinico Humanitas, Rozzano (MI)

20132

Fondazione Centro San Raffaele del Monte Tabor, Milan

20162

Ospedale Niguarda Milano, Milan

24116

University of Schleswig-Holstein, Kiel

28040

Fundacion Jimenez Daaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

37007

Hospital Universitario de Salamanca, Salamanca

38120

The West Clinic, Memphis

41013

Hospital Universitario Virgen Del Rocio, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

43210

Ohio State University Medical CenterJames Cancer Hospital, Columbus

45147

Universitaetsklinikum EssenInnere Klinik und Poliklinik, Essen

50937

Universitat zu Koln, Cologne

77030

MD Anderson Cancer Center The University of Texas, Houston

92093

University of California San Diego, La Jolla

97080

Universitatsklinikum Würzburg, Würzburg

98118

Fred Hutchinson Cancer Research Center, Seattle

02115

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

08035

Hospital Universitario Vall D hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY