Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients with Relapsed/refractory CLL

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

February 11, 2021

Study Completion Date

September 26, 2023

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

Acalabrutinib

"Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 100mg p.o.~Maintenance: Cycle 1 - 8: d1-84: 2 x 100mg 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 (17)

1307

Gemeinschaftspraxis Hämatologie Onkologie, Dresden

Gemeinschaftspraxis Mohm/Prange-Krex, Dresden

Universitatsklinik Carl Gustav Carus, Dresden

4683

Praxis Dr. Uhlig, Naunhof

7747

Universitaetsklinikum Jena, Jena

18057

Universitätsklinik Rostock, Rostock

50937

Universitätsklinik Köln, Cologne

51375

Klinikum Leverkusen GmbH, Leverkusen

53721

ZAHO-Rheinland, Siegburg

56068

Praxis fuer Haematologie und Onkologie, Koblenz

66822

Gemeinschaftspraxis Haemato/ Onkologie Lebach, Lebach

69120

Universitaetsklinikum Heidelberg, Heidelberg

72076

Universitaetsklinik Tuebingen, Tübingen

80804

Krankenhaus Muenchen-Schwabing, Munich

81377

Ludwig-Maximilians-Universitaet Muenchen, München

89081

Universitätsklinikum Ulm, Ulm

99089

Helios Klinikum Erfurt, Erfurt

All Listed Sponsors
lead

German CLL Study Group

OTHER

NCT03787264 - Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients with Relapsed/refractory CLL | Biotech Hunter | Biotech Hunter