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

NCT04271956 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-12-30

No results posted yet for this study

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

Conditions

  • Richter Transformation

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

Sponsors & Collaborators

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Barbara Eichhorst, Prof. · Department I of Internal Medicine, University Hospital Cologne

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Austria
  • Denmark
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271956 on ClinicalTrials.gov