A Phase II Study Evaluating the Safety and Efficacy of the Combination of Zanubrutinib Plus Lisocabtagene Maraleucel for Richter's Syndrome
Aseel Alsouqi
Summary
This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of zanubrutinib and lisocabtagene maraleucel (liso-cel) for the treatment of Richter's syndrome (RS). SECONDARY OBJECTIVES: I. To describe the safety profile of the combination of zanubrutinib and liso-cel for RS. II. To evaluate duration of the efficacy of the combination of zanubrutinib and liso-cel for RS CORRELATIVE OBJECTIVES: I. Describe T-cell subsets before and after zanubrutinib initiation, as well as post liso-cel infusion. II. To describe the persistence of liso-cel. III. To describe the tumor microenvironment…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of RS - occurrence of diffuse large B-cell lymphoma (DLBCL) in patients with antecedent or concurrent CLL/SLL (CLL/SLL diagnosis per IWCLL 2018 criteria). * Must have relapsed/refractory disease as defined by one of the following: * Participants must have undergone \>= 1 prior systemic therapeutic regimen administered for \>= 1 cycle for either CLL or RS, and have had either documented disease progression to the most recent treatment regimen, or refractory disease. OR * Developed RS while receiving treatment for CLL * Age \>= 18 years * Eastern Cooperative…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Biopsy
Undergo BM biopsy
- ProcedureComputed Tomography
Undergo CT and/or PET/CT
- DrugCyclophosphamide
Given IV
- DrugFludarabine
Given IV
- ProcedureLeukapheresis
Given IV
- BiologicalLisocabtagene Maraleucel
Given IV
Locations (3)
- Icahn School of Medicine at Mount SinaiNew York, New York
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Huntsman Cancer InstituteSalt Lake City, Utah