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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05820841 | Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma | PHASE3 | RECRUITING | 330 | — | — | Jun 7, 2023 | Dec 1, 2028 | Aug 31, 2023 | 17 | Germany |
PFS, defined by the time between the day of randomization until one of the following events occurs, whichever comes first: Disease progression (PD), relapse after complete remission (CR) or death due to any cause, as per Lugano Classification of 2014. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
| Arm | Type | Description |
|---|---|---|
| Standard arm | ACTIVE_COMPARATOR | 6x R-miniCHOP + 2x Rituximab. |
| Experimental arm | EXPERIMENTAL | 6x R-miniCHOP + 2x Rituximab + Acalabrutinib. |
| Name | Type | Description |
|---|---|---|
| R-miniCHOP + Acalabrutinib | DRUG | * Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5) * Acalabrutinib 100 mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously to D21 of cycle 8. Cycles repeated every 3 weeks |
| R-miniCHOP | DRUG | * Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5). Cycles repeated every 3 weeks |
Inclusion Criteria: Informed consent 1. Ability to understand the purpose and risks of the study and capable of giving signed informed consent which includes: 1. Compliance with the requirements and restrictions listed in the informed consent form (ICF). 2. Authorization to use protected he...