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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05495464 | A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 22 | — | — | Nov 18, 2022 | Mar 31, 2027 | May 20, 2026 | 1 | United States |
Unacceptable toxicity is defined as any grade 3 or higher treatment related toxicities happened within 30 days after CAR T-cell infusion. Will monitor the unacceptable toxicity for two patient cohorts together using the Bayesian stopping boundaries calculated based on beta-binomial distribution. The regimen will be considered excessively toxic if the unacceptable toxicity rate at 30 days after CAR T infusion is above 30%. Frequency tables will be used to summarize categorical variables such as toxicity type/severity.
| Arm | Type | Description |
|---|---|---|
| Acalabrutinib and Rituximab (Part 1) | EXPERIMENTAL | Participants may receive acalabrutinib and rituximab for up to 12 cycles. Each cycle is 28 days. |
| Brexucabtagene Autoleucel (Part 2) | EXPERIMENTAL | Participants will have a procedure called leukapheresis to collect enough T cells. |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Given by PO |
| Rituximab | DRUG | Given by IV (vein) |
| Brexucabtagene Autoleucel | OTHER | Given by IV (vein) |
| Cyclophosphamide | DRUG | Given by IV (vein) |
| Fludarabine Phosphate | DRUG | Given by IV (vein) |
Inclusion Criteria: 1. Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of chromosome translocation t(11;14), (q13;q32) and/or overexpression of cyclin D1 in tissue biopsy (See Appendix I, footnote 10)....