NCT05657652Recruiting
CAV Regimen for R/R Ph- B-ALL
Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Philadelphia Chromosome-negative (Ph-) B-cell Acute Lymphoblastic Leukemia (B-ALL): a Single-arm, Multicenter Study
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 12 Dec 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- NCT number
- NCT05657652
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Oct 2022 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
Other illness
- Patients who are allergic to the study drug or drugs with similar chemical structures.
- 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.
Lab values
- 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.
Age
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
Other
- Patients not suitable for the study according to the investigator's assessment.
Who the study is looking for
- 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.
Age in the registry: 15 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.