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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05971251 | Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia | PHASE1 | ACTIVE NOT_RECRUITING | 24 | — | — | Dec 18, 2023 | Dec 31, 2028 | Oct 1, 2025 | 1 | United States |
Recommended phase 2 dose of loncastuximab tesirine in combination with acalabrutinib
| Arm | Type | Description |
|---|---|---|
| Dose Level 1: | EXPERIMENTAL | 45 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles |
| Dose Level 2 | EXPERIMENTAL | 60 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles |
| Dose Level 3 | EXPERIMENTAL | 75 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles |
| Dose level 4: | EXPERIMENTAL | 90 µg /kg Loncastuximab Tesirine (for first 2 cycles followed by 75µg/kg for subsequent 10 cycles) + Acalabrutinib 100 mg BID for a total of 12 cycles. |
| Name | Type | Description |
|---|---|---|
| Loncastuximab Tesirine and Acalabrutinib | DRUG | Will be given on Day 1 of each cycle with each cycle being 21 days, and is being added to BID Acalabrutinib |
Inclusion Criteria: \- Inclusion Criteria For all patients 1. Diagnosis of CLL according to the IwCLL criteria or SLL according to the World Health Organization (WHO) criteria. This includes previous documentation of: * Biopsy-proven small lymphocytic lymphoma OR * Diagnosis of CLL accordin...