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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04624633 | Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL | PHASE2 | ACTIVE NOT_RECRUITING | 29 | — | — | Dec 15, 2020 | Jan 1, 2028 | Feb 25, 2026 | 1 | United States |
The CR Rate is defined as the proportion of participants achieving complete remission (CR) based on 2018 IW-CLL criteria.
| Arm | Type | Description |
|---|---|---|
| Cohort 1-Relapsed Disease | EXPERIMENTAL | Participants with relapsed disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years |
| Cohort 2-Treatment Naive | EXPERIMENTAL | Participants with previously untreated disease * Treatment with Acalabrutinib \& Umbralisib beginning C1D1, * Ublituximab beginning C7D1 * Assessment of treatment response * Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Oral, twice a day, predetermined dosage |
| Umbralisib | DRUG | Oral, once a day, predetermined dosage, each 28 day cycle up to 24 cycles |
| Ublituximab | DRUG | 28 day cycle, starting cycle 7 via iv, on at predetermined dosage and timepoints in each cycle |
Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) per International Workshop on CLL (iwCLL) 2018 criteria.1 * Participants must have an indication for treatment as defined by iwCLL 2018 criteria.1 * Participants must have measurable ...