Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Chronic Lymphoid Leukemia
Interventions
DRUG

Bendamustine

Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.

BIOLOGICAL

Obinutuzumab

"Induction: Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg i.v.; Cycle 2 - 6: 1000 mg, d1 i.v.~Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v."

BIOLOGICAL

Zanubrutinib

"Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 160mg p.o.~Maintenance: Cycle 1 - 8: d1-84: 2 x 160mg p.o"

BIOLOGICAL

Venetoclax

"Induction: Cycles 1 + 2: --; Cycle 3: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg p.o.; Cycle 4 - 6: d1-28: 400 mg p.o.~Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o."

Trial Locations (11)

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel

41063

KH Kliniken Maria Hilf, Mönchengladbach

50937

Universitätsklinik Köln, Cologne

59063

Evangelische Krankenhaus Hamm, Hamm

66424

Universitaetskliniken des Saarlandes, Homburg

73557

Stauferklinikum Schwaebisch-Gmuend, Mutlangen

73728

Onkologische Schwerpunktpraxis, Esslingen am Neckar

81675

Klinikum Rechts der Isar - Technische Universitaet Muenchen, Munich

86150

Hamatologische/Onkologische Gemeinschaftspraxis, Augsburg

89081

Universitätsklinik Ulm, Ulm

97080

Hämatologisch Onkologische Schwerpunktpraxis, Würzburg

All Listed Sponsors
lead

German CLL Study Group

OTHER