RecruitingPhase 2NCT04271956

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

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).


Sponsor

German CLL Study Group

Enrollment

83 participants

Start Date

Feb 19, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sonrotoclax, a biological treatment called Tislelizumab, and others for people with richter transformation. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTislelizumab

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

DRUGZanubrutinib

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

DRUGSonrotoclax

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

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NCT04271956


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