NCT07311746

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control the disease in patients with R/R T-PLL.

Detailed description

Primary Objective: • To evaluate the safety and tolerability of Ruxolitinib in combination with Cladribine and Venetoclax in patients with R/R T-PLL. Secondary Objectives: * To evaluate the EFS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax. * To evaluate response (CR, including CRi, or PR) of Ruxolitinib in combination with Cladribine and Venetoclax in patients with T-PLL. * To assess the time to response, response duration, and OS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax. Exploratory Objective: • To explore correlation of genomic profile, baseline patient and disease characteristics, and response to BCL-2 inhibition.

Conditions

• T-cell Prolymphocytic Leukemia
• Refractory T-Cell Prolymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Given orally
DRUG	Cladribine	Given by injection
DRUG	Venetoclax	Taken by mouth

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-01-31
• Completion: 2031-01-31
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study