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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04626791 | Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma | PHASE2 | RECRUITING | 45 | — | — | Aug 3, 2021 | Aug 3, 2028 | Mar 12, 2024 | 7 | United States |
Measured according to Lugano criteria. A success is defined as a CMR as the objective status at the end of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 9% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
| Arm | Type | Description |
|---|---|---|
| Treatment (modified VR-CAP, acalabrutinib) | EXPERIMENTAL | CYCLES 1, 3, AND 5: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive bortezomib SC on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) IV, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5. CYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Given PO |
| Bortezomib | DRUG | Given SC |
| Cyclophosphamide | DRUG | Given IV |
| Cytarabine | DRUG | Given IV |
| Doxorubicin Hydrochloride | DRUG | Given IV |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Rituximab and Hyaluronidase Human | BIOLOGICAL | Given IV |
Inclusion Criteria: * Age 18-75 years * No prior therapy for mantle cell lymphoma (MCL) * MCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician * Documented histological confirmation of MCL by local institutional review * Documented, fludeoxyglucos...