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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05583149 | Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas | PHASE2 | ACTIVE NOT_RECRUITING | 28 | — | — | Mar 1, 2023 | Mar 1, 2029 | Jan 29, 2026 | 2 | United States |
The CRR is defined as the percentage of subjects achieving an objective response of complete response (CR) according to the Lugano Classification (Chesson et al., 2014), prior to start of another non-study anticancer therapy. CR is defined as a complete metabolic and radiologic response (Lugano score 1-3, target nodes/nodal masses must regress to ≤ 1.5 cm in longest diameter.)
| Arm | Type | Description |
|---|---|---|
| ACALABRUTINIB and LISOCABTAGENE MARALEUCEL | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, as tolerated for one year * Liso-cel * Acalabrutinib |
| Name | Type | Description |
|---|---|---|
| ACALABRUTINIB | DRUG | Oral, twice daily, timing and dosage per protocol |
| LISOCABTAGENE MARALEUCEL | DRUG | via IV timings and dosage per protocol |
| Lymphodepleting chemotherapy | DRUG | lymphodepleting chemotherapy with cyclophosphamide and fludarabine once a day for 3 days via IV about 2-4 hours. This will occur only once prior to lisocabtagene maraleucel infusion. |
Inclusion Criteria: * Adult patients ≥18 years with histologically confirmed aggressive B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, and including DLBCL NOS, T cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr vi...