Actively Recruiting

Phase 2
Age: 16Years - 70Years
All Genders
NCT05657639

CAV Regimen for R/R AML

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

68

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Soochow University

Lead Sponsor

T

The Second People's Hospital of Huai'an

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (CAV regimen) for relapsed/refractory acute myeloid leukemia (R/R AML).

CONDITIONS

Official Title

CAV Regimen for R/R AML

Who Can Participate

Age: 16Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 16-70 years old
  • Diagnosed with relapsed or refractory acute myeloid leukemia (R/R AML)
  • Refractory AML defined as failure to achieve complete remission after at least 2 courses of standard or intensive induction therapy or bone marrow leukemia cell decline index less than 50% and more than 20% after 1 course of induction therapy
  • Relapsed AML defined as reappearance of leukemic blasts in peripheral blood after complete remission, or 5% or more blasts in bone marrow not due to other causes, or extramedullary relapse
  • ECOG performance status score less than 2
  • Expected survival time of at least 12 weeks
  • No serious heart, lung, liver, or kidney dysfunction
  • Able to understand and provide informed consent
Not Eligible

You will not qualify if you...

  • Allergy to the study drug or similar drugs
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception if a woman of childbearing age
  • Active infection or active bleeding
  • New thrombosis, embolism, cerebral hemorrhage, or similar diseases within one year before enrollment
  • Mental disorders or other medical conditions
  • Liver function abnormalities above specified limits or renal dysfunction (creatinine clearance less than 50 ml/h)
  • History of significant heart rhythm problems, recent myocardial infarction, congestive heart failure, or symptomatic coronary heart disease requiring treatment
  • Relapse after allogeneic hematopoietic stem cell transplantation
  • Drug or long-term alcohol abuse affecting evaluation
  • Previous organ transplant
  • Investigator's assessment of unsuitability for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

S

Sheng-Li Xue, M. D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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CAV Regimen for R/R AML | DecenTrialz