This study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).
Patients with relapse/refractory (R/R) acute myeloid leukemia often show resistance to conventional chemotherapy and have dismal prognosis. Salvage therapy using venetoclax combined with hypomethylation drugs achieved an overall response rate of only approximately 40% in R/R AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells.The efficacy of cladribine plus cytarabine and venetoclax in R/R AML has not been reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Cladribine 5 mg/m2/day , cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.
Mitoxantrone 8mg/m2 d1-5, etoposide 100mg/m2 d1-5, cytarabine 1g/m2 d1-5
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate (ORR)
The overall response (completed remission, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission)
Time frame: ORR assessment is measured on days 21 from the start of CAV regimen
Overall Survival (OS)
OS is measured from the time of enrollment to this study to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Time frame: 2 years
Event-free survival (EFS)
EFS is measured from the time of enrollment to this study to treatment failure or relapse or any cause of death.
Time frame: 2 years
Treatment-related mortality (TRM)
Death due to treatment (within 8 weeks) during and after completion of chemotherapy.
Time frame: 2 months
Adverse events (AEs)
It is evaluated and graded according to CTCAE 5.0.
Time frame: 2 months
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