Under construction – not a live service
Sign in
Taking people in ChinaPhase 2

Tests a drug combination in adults with relapsed or hard-to-treat acute myeloid leukemia

Tests cladribine, low-dose cytarabine and venetoclax in people with returned or resistant leukemia.

Plain-language title generated from the registry record
Registry title: CAV Regimen for R/R AML

Key facts

Where
Suzhou, ChinaSee the site
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16-70 whose acute myeloid leukemia (AML) has come back or has not responded to earlier treatment. It tests cladribine with low-dose cytarabine and venetoclax.

Age
16 to 70 years
Sex
All sexes can join.
Disease stage
Acute myeloid leukemia that has relapsed or did not respond to treatment (relapsed/refractory AML). Refractory means no complete remission after at least 2 courses of standard or intensive induction therapy, or a bone marrow leukemia cell decline index (BMCDI) of less than 50% and more than 20% after 1 course. Relapsed means leukemic blasts reappear in the blood after remission, 5% or more blasts in the bone marrow, or relapse outside the bone marrow.
Earlier treatment
Refractory disease: at least 2 courses of standard or intensive induction therapy without remission, or 1 course with a bone marrow leukemia cell decline index (BMCDI) between 20% and 50%. People who relapsed after an allogeneic stem cell transplant cannot join. People who have had an organ transplant cannot join.

Main reasons for not taking part

  • Allergy to the study drugs or drugs with a similar chemical structure
  • Pregnant or breastfeeding women, or women who can have children and do not want to use effective contraception
  • Active infection or active bleeding
  • Serious heart, lung, liver or kidney problems, including certain heart rhythm problems and heart attack within one year
  • Relapse after an allogeneic stem cell transplant, or any organ transplant

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 70 years old?

Source: NCT05657639, who can take part

Where in China

  • The First Affliated Hospital of Soochow UniversitySuzhou, ChinaContact: Sheng-Li Xue, M.D.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
The First Affiliated Hospital of Soochow University
Trial code
NCT05657639
Record updated
29 December 2025
Original description
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).Read full original descriptionShow less

Venetoclax, Cladribine Plus Low-dose Cytarabine for Relapsed/Refractory Acute Myeloid Leukemia: a Multicenter, Randomized, Controlled Study

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).

Inclusion: Aged 16-70 years old; Diagnosed with R/R AML; Patients with AML must meet one of the following criteria, A or B: A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML 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. 5. Expected survival time ≥12 weeks. 6. Without serious heart, lung, liver, or kidney dysfunction. 7. Able to understand and provide informed consent.

Exclusion: Patients who relapsed after allogeneic hematopoietic stem cell transplantation; Drug abuse or long-term alcohol abuse that would affect the evaluation results; Patients who have received organ transplants; Patients who are allergic to the study drug or drugs with similar chemical structures; 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 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; Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception; Patients not suitable for the study according to the investigator's assessment.

ClinicalTrials.gov NCT05657639