🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05657652
Recruiting Not applicable

CAV Regimen for R/R Ph- B-ALL

NCT05657652 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Soochow University
Phase
Not applicable
Started
2022-10-01
Last updated
2025-12-29

Condition(s) studied

Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

cladribine, cytarabine,venetoclax

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
15 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 15-70 years old. 2. Patients diagnosed with R/R Ph- B-ALL. 3. Patients with ALL must meet one of the following criteria, A or B: A: Refractory ALL disease was defined as follows: (1) failure to attain CR following exposure to at least 1 courses of standard induction therapy; B: Relapsed ALL disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse. 4. ECOG performance status score less than 2. 5. Expected survival time ≥ 12 weeks. 6. Patients without serious heart, lung, liver, or kidney dysfunction. 7. Able to understand and provide informed consent. Exclusion Criteria: 1. Patients who are allergic to the study drug or drugs with similar chemical structures. 2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. Active infection. 4. Active bleeding. 5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. Patients with mental disorders or other conditions. 7. Liver function abnormalities (total bilirubin \> 1.5 times of the upper limit of the normal range, ALT/AST \> 2.5 times of the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times of the upper limit of the normal range), or renal dysfunction (Ccr\<50ml/h). 8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. Surgery on the main organs within the past six weeks. 10. Drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. Patients who have received organ transplants. 12. Patients not suitable for the study according to the investigator's assessment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting

More The First Affiliated Hospital of Soochow University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05657652 on ClinicalTrials.gov ↗ ← All trials in China