DCLLSG

CLL-RT1 Trial

Title 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
Protocol IDs EudraCT: 2018-002492-17
NCT04271956
Participating Countries Germany, Austria, Denmark
Status Recruiting
Contact Medical Management: Dr. Othman Al-Sawaf

Dr. Othman Al-Sawaf
+49 221 478-88220 (Office)
othman.al-sawaf@uk-koeln.de

Project Management:
Miriam Schüler-Aparicio

Miriam Schüler-Aparicio
+49 221 478-96119
miriam.schueler-aparicio@uk-koeln.de

Dr. Emily Holmes

Dr. Emily Holmes
+49 221 478-96118
emily.van-der-poel-holmes@uk-koeln.de

Data Management:
Henrik Gerwin

Henrik Gerwin
+49 221 478-88177
henrik.gerwin@uk-koeln.de

Jan-Erik Mittler

Jan-Erik Mittler
+49 221 478-88199
jan-erik.mittler@uk-koeln.de

Safety Management: Sabine Frohs

Sabine Frohs
+49 221 478-89621
sabine.frohs@uk-koeln.de

Contact for scientific queries Prof. Dr. Barbara Eichhorst

Prof. Dr. Barbara Eichhorst
+49 221 478-88155 (Sekretariat)
barbara.eichhorst@uk-koeln.de

Dr. Othman Al-Sawaf

Dr. Othman Al-Sawaf
+49 221 478-88220 (Office)
othman.al-sawaf@uk-koeln.de

Design Prospective, multicenter, single-arm, open-label phase-II trial
Objective To evaluate the efficacy and the safety of the combinational therapy
Primary Endpoint Overall response rate (ORR) after induction therapy (6 cycles)
according to the refined Lugano Classification (Cheson et al, 2016)
- Complete response (CR)
- Partial response (PR)
Secondary Endpoints - ORR after induction therapy (6 cycles) according to iwCLL Kriterien (Hallek et al, 2018)
- ORR after consolidation therapy (i.e. 12 cycles)
- Duration of response
- Progression-free survival (PFS)
- Overall survival (OS)
- Time to next treatment (TTNT)
- Proportion of patients receiving SCT for consolidation
- Exploratory endpoints: Evaluation of relationship between various
baseline markers, including PD-1/PD-L1 expression and
mutational load, and clinical outcome parameters
- Safety parameters: type, frequency, severity of adverse
events (AEs), and their relationship to study treatment
Target Population - Confirmed B-CLL according to iwCLL criteria
- Confirmed histopathological diagnosis of Richter Transformation (RT)
- Previously untreated RT or up to 1 RT therapy with response
- ECOG performance status 0 – 2 (ECOG 3 only permitted if related to CLL or RT)
- Age  ≥ 18 years
Treatment Induction
6 Cycles, q 21d
Tislelizumab i.v.
Cycle 1 - 6: 200 mg, d1
+ Zanubrutinib p.o.
Cycle 1 - 6: 160 mg, twice daily
Consolidation
6 Cycles, q 21d
Tislelizumab i.v.
Cycle 7 - 12: 200 mg, d1
+ Zanubrutinib p.o.
Cycle 7 - 12: 160 mg, twice daily
Maintenance
Patients with response to therapy continue to take both agents until
- disease progression,
- non-tolerance or when
- receiving allogenic SCT for consolidation
Targeted Accrual 48 patients
Time schedule Recruitment period: Q1/2020 - Q1/2022
End of study: Q2/2023
Protocol Version 19 Jun 2019 Protocol (Version 1.2)
Sponsor University of Cologne
Principal Investigator Prof. Dr. Barbara Eichhorst, Department I of Internal Medicine, University Hospital of Cologne
Coordinating Physician Dr. Othman Al-Sawaf, Department I of Internal Medicine, University Hospital of Cologne
Documents
(publicly available)
Synopsis (Version 1.2 | 19 Jun 2019)
Documents
(password protected)
Protocol and other documents see Download Center