Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
M.D. Anderson Cancer Center
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.
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 Objec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment. 2. Age ≥ 18 years. * Patients must not have had T-PLL directed chemotherapy or antibody therapy for 7 days prior to starting ruxolitinib. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol. * Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational re…
Interventions
- DrugRuxolitinib
Given orally
- DrugCladribine
Given by injection
- DrugVenetoclax
Taken by mouth
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas