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

NCT04271956 ↗

Phase 2 Recruiting 83 enrolled German CLL Study Group

Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start: 2020-02-19
Primary completion: 2026-08
Completion: 2026-08

Outcome

Met primary endpoint

paper meeting the study's primary end point by rejecting the predefined null hypothesis of 40% (P = 0.008). PMID 38071379 ↗

Publications

Al-Sawaf O, Ligtvoet R, Robrecht S, Stumpf J, Fink AM, Tausch E, Schneider C, Boettcher S, Mikusko M, Ritgen M, Schetelig J, von Tresckow J, Vehling-Kaiser U, Gaska T, Wendtner CM, Chapuy B, Fischer K, Kreuzer KA, Stilgenbauer S, Staber P, Niemann C, Hallek M, Eichhorst B. Tislelizumab plus zanubrutinib for Richter transformation: the phase 2 RT1 trial. Nat Med. 2024 Jan;30(1):240-248. doi: 10.1038/s41591-023-02722-9. Epub 2023 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sonrotoclax	Other / unclassified	320 mg	Oral
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Zanubrutinib	Small molecule	160 mg	Oral