Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
A Phase II Study Evaluating the Safety and Efficacy of the Combination of Zanubrutinib Plus Lisocabtagene Maraleucel for Richter's Syndrome
Aseel Alsouqi
24 participants
Jul 28, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Undergo collection of blood samples
Undergo BM biopsy
Undergo CT and/or PET/CT
Given IV
Given IV
Given IV
Given IV
Undergo lymph node biopsy
Undergo PET/CT
Given PO
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05873712