To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Dose escalation up to 80 mg administered orally
1.4 mg/m2 i.v. weekly for 4 weeks
1 mg/kg orally 5 consecutive days per week for 4 weeks.
Establish optimal dose of ruxolitinib
Determine maximum tolerated dose (MTD) of ruxolitinib
Time frame: Upon completion of a 28 day treatment cycle
Evaluate safety by assessing toxicities
Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.
Time frame: Upon completion of a 28 day treatment cycle
Overall response
Time frame: At the end of Cycle 2 (each cycle is 60 days)
Complete response
Time frame: At the end of Cycle 2 (each cycle is 60 days)
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