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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04075292 | Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia | PHASE3 | ACTIVE NOT_RECRUITING | 155 | — | — | Jan 20, 2020 | Jan 1, 2027 | Mar 5, 2026 | 46 | China, Philippines +3 |
PFS was defined as the time from randomization to PD (assessed by BICR according to International Workshop on Chronic Lymphocytic Leukaemia \[iwCLL\] 2018 guideline criteria) or death due to any cause. PD was defined as meeting at least 1 of the below criteria of groups(g) A or B. gA: increase of ≥50% from baseline (BL) or from response in lymph nodes or liver and/or spleen size; any constitutional symptoms; increase of ≥50% over nadir with absolute count ≥ 5×10\^9/liter (L) in circulating lymphocyte count (CLC); gB: decrease of ≥50% from BL secondary to CLL in platelet count; decrease of ≥2 gram per deciliter (g/dL) from BL secondary to CLL in hemoglobin (Hb); increase of CLL cells by ≥50% on successive biopsies in bone marrow (BM). Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
| Arm | Type | Description |
|---|---|---|
| Acalabrutinib | EXPERIMENTAL | Acalabrutinib will be orally administered until disease progression or unacceptable toxicity |
| Rituximab and Chlorambucil | ACTIVE_COMPARATOR | Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | acalabrutinib 100 mg twice daily orally |
| Rituximab | DRUG | Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6) |
| Chlorambucil | DRUG | Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6 |
Inclusion Criteria: * Men and women: (a) ≥65 years of age OR (b) \>18 and \<65 years of age, provided that they meet at least one of the following criteria: (i) Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation (iwCLL guidelines) (ii) A score higher than 6 on the Cumulative Il...