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Recruiting NCT05657652

CAV Regimen for R/R Ph- B-ALL

No phase Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cladribine, cytarabine,venetoclax.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 15 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Relapse is common in Ph- B-ALL and a proportion of patients present refractory to initial treatment. Treatments for these patients consist immunotherapy and conventional chemotherapy. The former is too expensive and the latter has a low remission rate. Treatment for R/R Ph- B-ALL still remains a challenge. The efficacy and safety of cladribine, venetoclax and cytarabine (CAV) has not been explored in ALL. Thus investigators design such a clinical trial to investigate the efficacy and safety of CAV regimen for R/R Ph- B-ALL.

Interventions

  • Drug 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.

Primary outcome measures

  • Overall response rate (ORR) [Time frame: ORR assessment is measured on days 21 from the start of CAV regimen]
Secondary outcome measures (3)
  • Overall Survival (OS) [Time frame: 2 years]
  • Progression-Free Survival (PFS) [Time frame: 2 years]
  • Adverse events [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT05657652 · SZBALL01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗