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

Sponsor
German CLL Study Group
Study ID
NCT04271956
Phase
PHASE2
Status
Recruiting
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Conditions

  • Richter Transformation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — BIOLOGICAL
    Cycle (q21d): Day 1: Tislelizumab i.v. 200 mg
  • Zanubrutinib — DRUG
    Cycle (q21d): Zanubrutinib p.o. 160 mg twice a day
  • Sonrotoclax — DRUG
    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

Study Details

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

Key Dates

Start date
Feb 19, 2020
Status verified
Dec 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tislelizumab + Zanubrutinib
    Induction: 6 cycles (q21d) of Tislelizumab + Zanubrutinib Consolidation: 6 cycles (q21d) of Tislelizumab + Zanubrutinib Maintenance: Patients with response to therapy continue to take Tislelizumab + Zanubrutinib (Q3W) until disease progression, non-tolerance or when receiving allogeneic stem cell transplantation (SCT) for consolidation
  • Experimental: Tislelizumab + Zanubrutinib + Sonrotoclax
    Induction: 6 cycles (q21d) of Tislelizumab + Zanubrutinib + Sonrotoclax Consolidation: 6 cycles (q21d) of Tislelizumab + Zanubrutinib + Sonrotoclax Maintenance: Patients with response to therapy continue to take Tislelizumab + Zanubrutinib (Q3W) + Sonrotoclax until disease progression, non-tolerance or when receiving allogeneic stem cell transplantation (SCT) for consolidation

Primary Outcome Measure

Overall response rate (ORR) after induction therapy according to the refined Lugano Classification (Cheson et al, 2016) [ Time Frame: 18 weeks ]

Central Contacts

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