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.
Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment.
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 regimen are eligible for this trial.
Pregnant women are excluded from this study because the agent used has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant or cardiac arrhythmia
Patient with documented hypersensitivity to any of the components of the therapy program.
Patients with known active, uncontrolled CNS leukemia will not be eligible.
Single group
Ruxolitinib
DrugGiven orally
Cladribine
DrugGiven by injection
Venetoclax
DrugTaken by mouth
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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