An interventional study of cladribine, cytarabine,venetoclax in Acute Lymphoblastic Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
This study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (CAV regimen) for relapsed/refractory (R/R) Philadelphia Chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL).
Relapse is common in Ph- B-ALL and a proportion of patients present refractory to initial treatment. Treatments for these patients consist immunotherapy and conventional chemotherapy. The former is too expensive and the latter has a low remission rate. Treatment for R/R Ph- B-ALL still remains a challenge. The efficacy and safety of cladribine, venetoclax and cytarabine (CAV) has not been explored in ALL. Thus investigators design such a clinical trial to investigate the efficacy and safety of CAV regimen for R/R Ph- B-ALL.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 36 is close to the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: cladribine, cytarabine,venetoclax
Cladribine 5 mg/m2/day, cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.
Overall response rate (ORR)
The overall response (completed remission, completed remission with incomplete blood count recovery)
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 trial 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
Progression-Free Survival (PFS)
PFS is measured from the time of enrollment to this study to progression or death.
Time frame: 2 years
Adverse events
It is evaluated and graded according to CTCAE 5.0.
Time frame: 1 month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma→
The First Affiliated Hospital of Soochow University