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Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation

StatusActive, Not Recruiting
PhasePhase 2
Started2023-06-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 10, 2026 → Aug 24, 2027
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-10-02
critical
Primary completion pushed: 2026-09-10 → 2027-08-24
Completion pushed: 2026-09-10 → 2027-08-24
2026-06-05
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 20→confirmed 9
Study sitesdetails revised at 2 of 2 sites
2025-12-10
minor
Study Status v5
Primary completion date2025-09-10→2026-09-10
Completion date2025-09-10→2026-09-10
2025-03-28
minor
Study Status, Contacts/Locations v4
Study sites1→2
2024-06-16
minor
Study Status v3
Re-verified, no change to tracked fields
Show 2 earlier versions
2023-06-12
minor
Study Status v2
Primary completion date2024-08-05→2025-09-10
Completion date2024-08-05→2025-09-10
Start dateestimated 2023-05-05→confirmed 2023-06-02
2023-03-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-01-03
minor
Original filing
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.
Trial Details
NCT Number NCT05672173
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Transformed Chronic Lymphocytic Leukemia, Refractory Transformed Chronic Lymphocytic Leukemia, Richter Syndrome
Enrollment 9 participants
Start Date 2023-06-02
Primary Completion 2027-08-24 (estimated)
Study Completion 2027-08-24 (estimated)
Updated on ClinicalTrials.gov 2026-10-01