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

ConditionRichter Transformation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGerman CLL Study Group

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of CLL according to iwCLL criteria (Hallek et al, 2018)

Confirmed histopathological diagnosis of RT (diffuse large B-cell lymphoma or Hodgkin's lymphoma [Hodgkin's lymphoma only when not eligible for more in-tensive treatment])

Previously untreated RT or patients with objective response or non-tolerance to first-line RT treatment

Absolute neutrophil count (ANC) ≥ 1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥ 500/mm3

Disqualifiers

Patients who did not respond to previous line of RT therapy (i.e. primary progressive patients)

Patients with more than one prior line of RT therapy

Allogenic stem cell transplantation within the last 100 days or signs of active GVHD after prior allogeneic stem cell transplantation within any time

Patients with confirmed PML

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Biological/Vaccine

    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

Treatment groups

83 Participants
are divided into 2 treatment groups
Group A: Tislelizumab + ZanubrutinibExperimental treatment 2 interventions
Group B: Tislelizumab + Zanubrutinib + SonrotoclaxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR) after induction therapy according to the refined Lugano Classification (Cheson et al, 2016)

Proportion of patients having achieved complete response (CR) or partial response (PR)

Time frame
18 weeks

Secondary outcomes

1

ORR after induction therapy according to the IWCLL criteria (Hallek et al, 2018)

Proportion of patients having achieved complete response (CR) or partial response (PR)

Time frame
18 weeks
2

ORR after consolidation therapy

Proportion of patients having achieved complete response (CR) or partial response (PR)

Time frame
36 weeks
3

Progression-free Survival (PFS)

Time from the date of registration to the date of first occurrence of disease progression or relapse (determined according to the IWCLL guidelines and Lugano classification) or death from any cause, whichever occurs first

Time frame
Up to 15 months
4

Overall Survival (OS)

Time from the date of registration to the date of death due to any cause

Time frame
Up to 15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German CLL Study Group

Lead sponsor

Source ClinicalTrials.gov
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