Phase 2 Study of the Combination of Lisocabtagene Maraleucel, Nivolumab, and Ibrutinib in Richter's Transformation
City of Hope Medical Center
Summary
This phase II trial tests how well adding lisocabtagene maraleucel (liso-cel) to nivolumab and ibrutinib works in treating patients with Richter's transformation. Liso-cel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared by using cells from patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells and other substances that cause disease) to fight the cancer cells. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the grown of cancer. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Giving ibrutinib and nivolumab with Liso-cel may kill more cancer cells in patients with Richter's transformation.
Description
PRIMARY OBJECTIVES: I. Evaluate the complete response (CR) rate after cycle 3 following lisocabtagene maraleucel (liso-cel) in combination with nivolumab and ibrutinib to treat patients with Richter's transformation (RT). II. Assess the Unacceptable toxicities (UT) rate within the first 28 days during cycle 1 following liso-cel infusion. (Safety lead-in only) SECONDARY OBJECTIVES: I. Assess the safety of liso-cel, nivolumab and ibrutinib to treat patients with RT. II. Estimate the best CR rate. III. Estimate the best overall response rate (ORR). IV. Estimate duration of response (DOR) at…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant * Agreement for confirmatory pre-treatment tumor biopsy * If a patient does not have an easily accessible lymph node to biopsy without excessive risk in the opinion of the investigator, archival biopsy material reviewed by a hematopathologist at the enrolling site for study eligibility and baseline correlatives may be acceptable with approval from the Study principal investigator (PI) * Age: \>= 18 years * Eastern cooperative oncology group (ECOG) \<= 2 * Histologically confirmed Richter's Transformation (RT) * Relapsed /…
Interventions
- ProcedureBiopsy
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood specimen collection
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and/or aspiration
- ProcedureComputed Tomography
Undergo PET/CT
- DrugCyclophosphamide
Given IV
- DrugFludarabine
Given IV
- DrugIbrutinib
Given PO
Locations (2)
- City of Hope Medical CenterDuarte, California
- Memorial Sloan Kettering Cancer CenterNew York, New York