A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

January 13, 2014

Primary Completion Date

August 17, 2018

Study Completion Date

August 11, 2020

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Bendamustine

Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter \[mg/m\^2\]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.

DRUG

Obinutuzumab

Participants will receive IV infusion of obinutuzumab (100 milligrams \[mg\]) on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.

DRUG

Rituximab

Participants will receive IV infusion of rituximab (375 mg/m\^2) on Day 1 of Cycle 1 and 500 mg/m\^2 administered on Day 1 of Cycles 2-6.

DRUG

Venetoclax

Participants will receive multiple doses of venetoclax orally once daily.

Trial Locations (12)

34295

Hopital Saint Eloi, Montpellier

48201

Karmanos Cancer Institute, Detroit

50924

Universitatsklinik Koln, Cologne

59037

Hopital Claude Huriez, Lille

60426

Ingalls Hospital; Cancer Clinical Trials, Harvey

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

76038

Centre Henri Becquerel, Rouen

79106

Apotheke des Universitätsklinikums Freiburg, Freiburg im Breisgau

80804

Klinikum Schwabing, München

89081

Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm

98902

North Star Lodge, Yakima

92093-5354

University of California San Diego Medical Center, La Jolla

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

lead

Genentech, Inc.

INDUSTRY

NCT01671904 - A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) | Biotech Hunter | Biotech Hunter