CAV Regimen for R/R Ph- B-ALL

Recruiting now · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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).

Key facts

Study ID

NCT05657652

Run by

The First Affiliated Hospital of Soochow University

People needed

36

Starts

2022-10-01

Expected to finish

2026-10-01

Last updated by the study team

2025-12-29

Who can join

Age: 15 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 15-70 years old.
• Patients diagnosed with R/R Ph- B-ALL.
• 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.
• ECOG performance status score less than 2.
• Expected survival time ≥ 12 weeks.
• Patients without serious heart, lung, liver, or kidney dysfunction.
• Able to understand and provide informed consent.

You may not qualify if…

• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• Active infection.
• Active bleeding.
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• Patients with mental disorders or other conditions.
• 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).
• 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.
• Surgery on the main organs within the past six weeks.
• Drug abuse or long-term alcohol abuse that would affect the evaluation results.
• Patients who have received organ transplants.
• Patients not suitable for the study according to the investigator's assessment.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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