NCT05197192 - A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL | Biotech Hunter

Enrollment

202

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions

Chronic Lymphocytic Leukemia

Interventions

DRUG

Obinutuzumab

"Obinutuzumab i.v. infusion:~Cycle 1 Day 1: Obinutuzumab 100 mg i.v.~Cycle 1 Day 1 (or 2): Obinutuzumab 900 mg i.v.~Cycle 1 Day 8: Obinutuzumab 1000 mg i.v.~Cycle 1 Day 15: Obinutuzumab 1000 mg i.v.~Cycles 2-6: Day 1: Obinutuzumab 1000 mg i.v."

DRUG

Venetoclax

"Venetoclax p.o.:~Cycle 1: Days 22-28: Venetoclax 20 mg (2 x 10 mg)~Cycle 2: Days 1-7: Venetoclax 50 mg (1 x 50 mg)~Cycle 2:Days 8-14: Venetoclax 100 mg (1 x 100 mg)~Cycle 2:Days: 15-21: Venetoclax 200 mg (2 x 100 mg)~Cycle 2:Days: 22-28: Venetoclax 400 mg (4 x 100 mg)~Cycles 3-12: Days 1-28: Venetoclax 400 mg (4 x 100 mg)"

DRUG

Acalabrutinib

"Cycles 15-24: Days 1-28:~100 mg acalabrutinib twice daily p.o. approx. every 12 hrs (corresponding to a total daily dose of 200 mg)."

Trial Locations (30)

12559

RECRUITING

DRK Kliniken Berlin Köpenick, Berlin

15526

RECRUITING

Helios Klinikum Bad Saarow, Bad Saarow

18057

RECRUITING

Universitätsklinik Rostock, Rostock

24116

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel

26133

RECRUITING

Klinikum Oldenburg, Oldenburg

28239

RECRUITING

Ev. Diakoniekrankenhaus, Bremen

32657

RECRUITING

Klinikum Lippe-Lemgo, Lemgo

33098

RECRUITING

Brüderkrankenhaus St. Josef Paderborn, Paderborn

39120

RECRUITING

Universitaetsklinikum Magdeburg, Magdeburg

40479

RECRUITING

Marien Hospital Düsseldorf, Düsseldorf

41063

RECRUITING

KH Kliniken Maria Hilf, Mönchengladbach

44137

RECRUITING

St. Johannes Hospital, Dortmund

45147

RECRUITING

Universitaetsklinikum Essen, Essen

50937

RECRUITING

Universitätsklinik Köln, Cologne

52249

RECRUITING

St. Antonius-Hospital, Eschweiler

55743

RECRUITING

Klinikum Idar-Oberstein SHG, Idar-Oberstein

58097

RECRUITING

Katholisches Krankenhaus Hagen - St. Josefs Hospital, Hagen

59872

RECRUITING

Klinikum Hochsauerland - St. Walburga Krankenhaus, Meschede

65549

RECRUITING

St Vincenz Krankenhaus, Limburg

66113

RECRUITING

Caritas-Klinik St. Theresia, Saarbrücken

66424

RECRUITING

Universitaetskliniken des Saarlandes, Homburg

70199

RECRUITING

Marienhospital Stuttgart, Stuttgart

71065

RECRUITING

Klinikum Sindelfingen-Böbingen, Sindelfingen

72076

RECRUITING

Universitaetsklinik Tuebingen, Tübingen

73557

RECRUITING

Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd, Mutlangen

76133

RECRUITING

Staedtisches Klinikum Karlsruhe, Karlsruhe

80804

RECRUITING

Krankenhaus Muenchen-Schwabing, Munich

81675

RECRUITING

Klinikum Rechts der Isar - Technische Universitaet Muenchen, Munich

84034

RECRUITING

Klinikum Landshut, Landshut

89081

RECRUITING

Universitätsklinik Ulm, Ulm