At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of CLL according to iwCLL criteria
- ✓Confirmed histopathological diagnosis of RT (DLBCL or Hodgkin's lymphoma)
- ✓Previously untreated RT or patients with objective response or non-tolerance to first-line RT treatment
- ✓Age at least 18 years
- ✕Patients who did not respond to previous line of RT therapy (primary progressive patients)
- ✕More than one prior line of RT therapy
- ✕Allogeneic stem cell transplantation within last 100 days or active GVHD after prior allogeneic transplantation
- ✕Confirmed PML
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open-label, Multicenter Phase-II Trial 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 with or Without Sonrotoclax（BGB-11417), a Bcl-2 Inhibitor (CLL-RT1-trial of the GCLLSG).
In Brief
A Phase 2 clinical trial evaluating Tislelizumab, Zanubrutinib, and 1 other intervention for Richter Transformation. Currently recruiting, targeting 83 participants across 11 sites in 3 countries.
Detailed 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
Study Details
Timeline
Interventions
Cycle (q21d): Day 1: Tislelizumab i.v. 200 mg
Cycle (q21d): Zanubrutinib p.o. 160 mg twice a day
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