Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05873712 | Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome | PHASE2 | RECRUITING | 24 | — | — | Jul 28, 2023 | Dec 31, 2026 | Mar 3, 2026 | 3 | United States |
Overall response rate (ORR) will be defined as the proportion of patients achieving a complete or partial response divided by the number of efficacy-evaluable patients according to the Revised Response Criteria for Malignant Lymphoma. Response will be assessed using Lugano criteria 2014. ORR will be reported with two-sided 95% and 80% binomial exact confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (zanubrutinib, liso-cel) | EXPERIMENTAL | Patients receive zanubrutinib PO BID for up to day 90 and undergo leukaphereis at least 14 days after starting zanubrutinib. Patients receive fludarabine IV and cyclophosphamide IV on days -5 to -3 and liso-cel IV over 5-30 minutes on day 0. Patients also undergo BM biopsy and lymph node biopsy at screening and follow up, and undergo collection of blood samples and CT, PET/CT, and/or MRI throughout the trial. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo collection of blood samples |
| Bone Marrow Biopsy | PROCEDURE | Undergo BM biopsy |
| Computed Tomography | PROCEDURE | Undergo CT and/or PET/CT |
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine | DRUG | Given IV |
| Leukapheresis | PROCEDURE | Given IV |
| Lisocabtagene Maraleucel | BIOLOGICAL | Given IV |
| Lymph Node Biopsy | PROCEDURE | Undergo lymph node biopsy |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Zanubrutinib | DRUG | Given PO |
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 undergon...