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Tests treatment safety and results for Richter Transformation
Official title Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation
ClinicalTrials.gov ID: NCT04271956
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for richter transformation.
Also referred to as BGB-A317.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Previously untreated RT or patients with objective response or non-tolerance to first-line RT treatment
- Adequate bone marrow function as defined by:
- Absolute neutrophil count (ANC) ≥ 1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥ 500/mm3
You likely can't join if
- 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
- Uncontrolled autoimmune condition
- Malignancies other than CLL currently requiring systemic therapies (unless the malignant disease is in a stable remission at the discretion of the...
See the full eligibility criteria
- 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
- Adequate bone marrow function as defined by:
- Absolute neutrophil count (ANC) ≥ 1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥ 500/mm3
- Platelet ≥ 75,000/mm3, except for patients with bone marrow involvement in which the platelet count must be ≥ 30,000/mm3
- Creatinine clearance ≥30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection or an equivalent method.
- Adequate liver function as indicated by a total bilirubin≤ 2 x, AST/ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL/RT or to Gilbert's Syndrome, in which case a max. total...
- Negative serological testing for hepatitis B (HBsAg negative and anti-HBc nega-tive; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every two months until 2...
- Age at least 18 years
- ECOG performance status 0-2, ECOG 3 is only permitted if related to CLL or RT (e.g. due to anaemia or severe constitutional symptoms)
- Life expectancy ≥ 3 months
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
- 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
- Uncontrolled autoimmune condition
- Malignancies other than CLL currently requiring systemic therapies (unless the malignant disease is in a stable remission at the discretion of the treating phy-sician)
- Uncontrolled infection currently requiring systemic treatment
- Any comorbidity or organ system impairment rated with a CIRS (cumulative ill-ness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system , or any other life-threatening illness, medical...
- Requirement of therapy with strong CYP3A4 inhibitors/ inducers
- Requirement of therapy with phenprocoumon or other vitamin K antagonists.
- Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core anti-body (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\< 20 IU), and...
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.
- Major surgery within 4 weeks of the first dose of study drug.
- Any uncontrolled or clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- New York Heart Association class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachy-cardia, ventricular fibrillation, torsades de pointes)
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood trans-fusion or other medical intervention
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- Severe or debilitating pulmonary disease
- Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory...
- Use of investigational agents, e.g. monoclonal antibodies or other experimental drugs within clinical trials, which might interfere with the study drug within 28 days (or 5 times half-life [t1/2] of the compound...
- Known hypersensitivity to tislelizumab, zanubrutinib, sonrotoclax or any of the excipients
- Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)
- Fertile men or women of childbearing potential unless:
- surgically sterile or ≥ 2 years after the onset of menopause, or
- willing to use two methods of reliable contraception including one highly ef-fective contraceptive method (Pearl Index \<1) and one additional effective (barrier) method during study treatment and for 6 months after the...
- Vaccination with a live vaccine \<28 days prior to randomization
- Legal incapacity
- Prisoners or people who are institutionalized by regulatory or court order
- Persons who are in dependence to the sponsor or an investigator
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Copenhagen, Denmark
- Berlin, State of Berlin, Germany
- Cologne, Germany
- Dresden, Germany
- Essen, Germany
- Kiel, Germany
- Landshut, Germany
- Paderborn, Germany
- Rostock, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Copenhagen, Denmark; Berlin, State of Berlin, Germany; Cologne, Germany; Dresden, Germany; Essen, Germany and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.