Treatment for relapsed or refractory B-cell acute lymphoblastic leukemia

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

This study is testing a new combination treatment for people with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia to see if it can help them respond better than current options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 15 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05657652 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a combination treatment regimen consisting of cladribine, venetoclax, and cytarabine (CAV) for patients with relapsed or refractory Philadelphia Chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL). The study aims to address the challenges faced by patients who have not responded to standard therapies, as current treatments often have low remission rates or are prohibitively expensive. By exploring the CAV regimen, the trial seeks to provide a new therapeutic option for this difficult-to-treat population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 15-70 years diagnosed with relapsed or refractory Philadelphia Chromosome-negative B-ALL.

Not a fit: Patients with serious heart, lung, liver, or kidney dysfunction, or those who are allergic to the study drugs, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with relapsed or refractory B-ALL, potentially improving their chances of remission.

How similar studies have performed: While the efficacy and safety of the CAV regimen have not been previously explored in ALL, similar combination therapies have shown promise in other hematological malignancies.

Eligibility criteria

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.

Where this trial is running

Suzhou, Jiangsu

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

Conditions Acute Lymphoblastic Leukemia; venetoclax; cladribine; cytarabine; relapsed/refractory ALL