Actively Recruiting

Phase Not Applicable
Age: 15Years - 70Years
All Genders
NCT05657652

CAV Regimen for R/R Ph- B-ALL

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-12-29

36

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Soochow University

Lead Sponsor

J

Jining Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

CAV Regimen for R/R Ph- B-ALL

Who Can Participate

Age: 15Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 15-70 years old.
  • Diagnosed with relapsed or refractory Philadelphia Chromosome-negative B-cell acute lymphoblastic leukemia.
  • For refractory disease: failure to achieve complete remission after at least one standard induction therapy.
  • For relapsed disease: reappearance of leukemic blasts in blood after remission, or 5% or more blasts in bone marrow not due to other causes, or extramedullary relapse.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
  • Expected survival time of at least 12 weeks.
  • No serious dysfunction of heart, lung, liver, or kidneys.
  • Able to understand and provide informed consent.
Not Eligible

You will not qualify if you...

  • Allergy to study drugs or similar chemicals.
  • Pregnant or breastfeeding women, or women of childbearing potential not practicing effective contraception.
  • Active infection or active bleeding.
  • New thrombosis, embolism, cerebral hemorrhage, or related conditions within one year before enrollment.
  • Mental disorders or other significant conditions.
  • Liver function abnormalities (total bilirubin >1.5 times normal, ALT/AST >2.5 times normal, or liver involvement with ALT/AST >1.5 times normal) or kidney dysfunction (creatinine clearance <50 ml/h).
  • History of significant heart rhythm issues, heart attack within one year, congestive heart failure, or symptomatic coronary heart disease requiring medication.
  • Surgery on major organs within the past six weeks.
  • Drug or long-term alcohol abuse affecting study evaluation.
  • Previous organ transplant.
  • Deemed unsuitable for the study by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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