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RECRUITING
NCT04271956
PHASE2

Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation

Sponsor: German CLL Study Group

View on ClinicalTrials.gov

Summary

The aim of the CLL-RT1 trial is to evaluate the efficacy and safety of zanubrutinib (BGB-3111), a BTK inhibitor plus tislelizumab (BGB-A317), a PD1 inhibitor for treatment of patients with Richter Transformation

Official title: A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of Zanubrutinib (BGB-3111), a BTK Inhibitor, Plus Tislelizumab (BGB-A317), a PD1 Inhibitor, for Treatment of Patients with Richter Transformation with or Without Sonrotoclax(BGB-11417), a Bcl-2 Inhibitor (CLL-RT1-trial of the GCLLSG).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2020-02-19

Completion Date

2026-08

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

Tislelizumab

Cycle (q21d): Day 1: Tislelizumab i.v. 200 mg

DRUG

Zanubrutinib

Cycle (q21d): Zanubrutinib p.o. 160 mg twice a day

DRUG

Sonrotoclax

Cycle 1: Sonrotoclax Start Ramp-up to 320 mg QD po Days 1-2 Sonrotoclax 2 mg (2 tabl. at 1mg) Days 3-4 Sonrotoclax 5 mg (1 tabl. at 5mg) Days 5-6 Sonrotoclax 10 mg (2 tabl. at 5mg) Days 7-8 Sonrotoclax 20 mg (1 tabl. at 20mg) Days 9-10 Sonrotoclax 40 mg (2 tabl. at 20mg) Days 11-12 Sonrotoclax 80 mg (1 tabl. at 80mg) Days 13-14 Sonrotoclax 160 mg (2 tabl. at 80mg) Days 15-16 Sonrotoclax 320 mg (4 tabl. at 80mg) Cycle 2-6: Day 1-21 Sonrotoclax 320 mg QD po

Locations (11)

Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Rigshospitalet

Copenhagen, Denmark

Charité Berlin

Berlin, State of Berlin, Germany

Uniklinik Köln

Cologne, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

H.O.T Praxis Landshut

Landshut, Germany

Brüderkrankenhaus St. Josef Paderborn

Paderborn, Germany

Universitätsmedizin Rostock

Rostock, Germany

Universitätsklinik Ulm

Ulm, Germany