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

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

Treatments tested in this trial

  • Tislelizumab
  • Zanubrutinib
  • Sonrotoclax

Treatment groups

83 Participants
are divided into 2 treatment groups

Sponsors and collaborators