CAV Regimen for R/R Ph- B-ALL

Last updated: December 9, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Lymphoproliferative Disorders

Platelet Disorders

Treatment

cladribine, cytarabine,venetoclax

Clinical Study ID

NCT05657652
SZBALL01
  • Ages 15-70
  • All Genders

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 Criteria

Inclusion

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 ALLdisease was defined as follows: (1) failure to attain CR following exposure to atleast 1 courses of standard induction therapy; B: Relapsed ALL disease was definedas 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., BMregeneration 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

Exclusion Criteria:

  1. Patients who are allergic to the study drug or drugs with similar chemicalstructures.

  2. Pregnant or lactating women, and women of childbearing age who do not want topractice effective methods of contraception.

  3. Active infection.

  4. Active bleeding.

  5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or amedical 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 thenormal range, ALT/AST > 2.5 times of the upper limit of the normal range or patientswith liver involvement whose ALT/AST > 1.5 times of the upper limit of the normalrange), 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 beforeenrollment, and congestive heart failure, and patients with coronary heart diseasewho 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.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: cladribine, cytarabine,venetoclax
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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