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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07029737 | A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain | PHASE2 | RECRUITING | 55 | — | — | Sep 5, 2025 | Dec 15, 2028 | May 7, 2026 | 22 | Spain |
Investigator-assessed best ORR (CR+PR) as per the Lugano Classification for NHL
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Acalabrutinib + R-CHOP standard of care (Induction Phase) plus Acalabrutinib + Rituximab (Maintenance Phase) / Acalabrutinib Monotherapy (Maintenance Phase) |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib + R-CHOP standard of care | DRUG | Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP standard of care up to six 21-day cycles of the induction phase. |
| Acalabrutinib combination with Rituximab | DRUG | If the subject achieves response during the induction phase, acalabrutinib will be administered 100 mg BID PO until disease progression and rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses. |
| Acalabrutinib monotherapy | DRUG | If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression. |
INCLUSION CRITERIA: 1. Adult men or women. 2. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers. 3. MCL requiring treatment and for which no prior systemic anticancer therapies...