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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07271667 | A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies | PHASE2 | RECRUITING | 108 | — | — | Apr 23, 2026 | Nov 1, 2027 | May 22, 2026 | 7 | United States, Italy +1 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Emavusertib and Zanubrutinib | EXPERIMENTAL | Participants in Cohort 1 include CLL participants who have been on zanubrutinib for at least 12 months and are currently in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+). In Part A, participants will receive one of two doses of emavusertib twice daily (BID) and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label. |
| Cohort 2: Emavusertib and Zanubrutinib | EXPERIMENTAL | Participants in Cohort 2 include relapsed CLL participants who have directly progressed on zanubrutinib after a confirmed response (PR or better lasting 6 months or longer). In Part A, participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label. |
| Name | Type | Description |
|---|---|---|
| Emavusertib | DRUG | Oral tablets |
| Zanubrutinib | DRUG | Oral capsules |
Inclusion Criteria (All Parts): 1. Males and females ≥ 18 years of age. 2. Life expectancy of ≥ 3 months. 3. Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2. 4. Histopathologically confirmed diagnosis of CLL (medical record is acceptable), as per the World Health Organization 20...