Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
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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