To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.
This study is a prospective, open, multiple -centered, sing-arm trial. The major aim of this studies to evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL. The study will include 50 subjects to receive CLAE regimen for reinduction chemotherapy.
Study Type
OBSERVATIONAL
Enrollment
50
CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL
ORR
Objective response rate,sum of complete response rate and partial response rate
Time frame: From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
PFS
progression-free survival
Time frame: From the date of first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
OS
overall survival
Time frame: From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.
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