Actively Recruiting
Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation
Led by German CLL Study Group · Updated on 2024-12-30
83
Participants Needed
11
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of CLL according to iwCLL criteria
- Confirmed histopathological diagnosis of Richter Transformation (diffuse large B-cell lymphoma or Hodgkin's lymphoma if not eligible for intensive treatment)
- Previously untreated RT or patients with response or intolerance to first-line RT treatment
- Adequate bone marrow function with specific thresholds for neutrophils and platelets
- Creatinine clearance of at least 30 ml/min
- Adequate liver function with defined limits on bilirubin and liver enzymes
- Negative hepatitis B, hepatitis C, and HIV tests within 6 weeks prior to registration
- Age at least 18 years
- ECOG performance status 0-2, or 3 if related to CLL or RT
- Life expectancy of at least 3 months
- Ability and willingness to give informed consent and follow study procedures
You will not qualify if you...
- No response to prior RT therapy (primary progressive disease)
- More than one prior line of RT therapy
- Allogeneic stem cell transplant within last 100 days or active graft-versus-host disease
- Confirmed progressive multifocal leukoencephalopathy (PML)
- Uncontrolled autoimmune disease
- Other malignancies requiring systemic therapy unless stable remission
- Uncontrolled infections requiring treatment
- Severe comorbidities or organ dysfunction affecting safety or drug metabolism
- Need for strong CYP3A4 inhibitors or inducers
- Use of vitamin K antagonists like phenprocoumon
- Active infections with HIV or hepatitis B or C unless specific monitoring criteria met
- Major surgery within 4 weeks before starting study drug
- Significant cardiovascular disease or recent serious cardiac events
- History of severe bleeding disorders or recent stroke
- Severe pulmonary disease
- Difficulty swallowing capsules or serious gastrointestinal conditions
- Use of other investigational drugs within 28 days or 5 half-lives prior to registration
- Known allergies to study drugs or their ingredients
- Pregnant or nursing women
- Fertile men or women not using effective contraception
- Live vaccination within 28 days before randomization
- Legal incapacity, incarceration, or institutionalization
- Dependence on the sponsor or investigator
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, 1090
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Charité Berlin
Berlin, State of Berlin, Germany, 12203
Not Yet Recruiting
4
Uniklinik Köln
Cologne, Germany, 50937
Actively Recruiting
5
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
6
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
7
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
8
H.O.T Praxis Landshut
Landshut, Germany, 84036
Actively Recruiting
9
Brüderkrankenhaus St. Josef Paderborn
Paderborn, Germany, 33098
Actively Recruiting
10
Universitätsmedizin Rostock
Rostock, Germany, 18057
Actively Recruiting
11
Universitätsklinik Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
B
Barbara Eichhorst, Prof.
CONTACT
O
Othman Al-Sawaf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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