Study of Ruxolitinib, Cladribine, and Venetoclax to Treat Adults With Relapsed or Refractory T-cell Prolymphocytic Leukemia

What this Trial Is About

Researchers are studying the combination of ruxolitinib, cladribine, and venetoclax to see if it can better control relapsed or refractory T-cell prolymphocytic leukemia T-PLL. This clinical trial aims to evaluate the safety and tolerability of these drugs together and to measure treatment responses, survival outcomes, and the relationship between genetic factors and treatment effects. Participants receive ruxolitinib orally twice daily starting on Day 1, cladribine by intravenous injection for specified days, and venetoclax orally with a ramp-up dose schedule during the first cycle. The study includes a Phase 1b dose escalation and expansion period, followed by a Phase II dose expansion at the maximum tolerated dose. Cladribine may be stopped once remission is achieved. Subsequent cycles continue the treatments with specific dosing schedules. During the trial, participants undergo safety monitoring for adverse events for about one year. Researchers assess treatment effectiveness by measuring response rates, time to response, duration of response, event-free survival, and overall survival. Participants will have laboratory tests, organ function assessments, pregnancy testing when applicable, and ongoing evaluations to monitor health and treatment effects throughout the study duration, which extends up to early 2031.

Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia