Actively Recruiting
CAV Regimen for R/R Ph- B-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-12-29
36
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
J
Jining Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
CAV Regimen for R/R Ph- B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 15-70 years old.
- Diagnosed with relapsed or refractory Philadelphia Chromosome-negative B-cell acute lymphoblastic leukemia.
- For refractory disease: failure to achieve complete remission after at least one standard induction therapy.
- For relapsed disease: reappearance of leukemic blasts in blood after remission, or 5% or more blasts in bone marrow not due to other causes, or extramedullary relapse.
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
- Expected survival time of at least 12 weeks.
- No serious dysfunction of heart, lung, liver, or kidneys.
- Able to understand and provide informed consent.
You will not qualify if you...
- Allergy to study drugs or similar chemicals.
- Pregnant or breastfeeding women, or women of childbearing potential not practicing effective contraception.
- Active infection or active bleeding.
- New thrombosis, embolism, cerebral hemorrhage, or related conditions within one year before enrollment.
- Mental disorders or other significant conditions.
- Liver function abnormalities (total bilirubin >1.5 times normal, ALT/AST >2.5 times normal, or liver involvement with ALT/AST >1.5 times normal) or kidney dysfunction (creatinine clearance <50 ml/h).
- History of significant heart rhythm issues, heart attack within one year, congestive heart failure, or symptomatic coronary heart disease requiring medication.
- Surgery on major organs within the past six weeks.
- Drug or long-term alcohol abuse affecting study evaluation.
- Previous organ transplant.
- Deemed unsuitable for the study by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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