Phase 1B pilot study of itacitinib with alemtuzumab in patients with T-cell prolymphocytic leukemia.

ABSTRACT: T-cell prolymphocytic leukemia (T-PLL) is a mature T-cell neoplasm with an aggressive clinical course. Overall prognosis is poor, and treatment relies on alemtuzumab because of inadequate response to conventional chemotherapy. Three-quarters of cases harbor activating mutations in the JAK-STAT pathway (JAK1, JAK3, STAT5B, IL2RG). We report safety and efficacy from a phase 1B study evaluating the combination of the JAK1 inhibitor itacitinib with alemtuzumab. Patients (N = 15) were aged >18 years, with treatment-naïve (n = 8) or relapsed/refractory (n = 7) T-PLL with adequate organ function, European Cooperative Oncology Group Performance Status ≤2, and platelet >30 × 10³/μL. Cycle 1 included a lead-in phase with itacitinib monotherapy days 1-14. Beginn

SUBMITTER: Kadia TM 

PROVIDER: S-EPMC12796981 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature