Compares two treatment combinations in relapsed or refractory acute myeloid leukemia
Tests adding venetoclax to CLAG in adults with returned acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
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 adults aged 18 to 65 with acute myeloid leukemia (AML) that has come back or has not responded to treatment. It compares CLAG plus venetoclax with CLAG alone.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (AML) that has relapsed or is refractory, meaning it came back or did not respond to treatment.
- Earlier treatment
- Refractory means no response to two courses of standard treatment, or relapse within 12 months after consolidation intensive therapy, or relapse after 12 months with no response to conventional chemotherapy. Two or more relapses, or persistent leukemia outside the bone marrow, also count.
Main reasons for not taking part
- Acute promyelocytic leukemia (AML-M3)
- Leukemia in the central nervous system
- Known HIV infection
- Uncontrolled or active infection, or hepatitis B or C needing treatment
- Pregnant or breastfeeding women
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 18 and 65 years old?
Source: NCT06763666, who can take part
Where in China
- Department of Hematology,Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Guopan YuNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nanfang Hospital, Southern Medical University
- Trial code
- NCT06763666
- Record updated
- 8 January 2025
- Original description
This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.Read full original descriptionShow less
A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.
Inclusion: Diagnosed of AML according to the World Health Organization (WHO) classification; All patients should aged 18 to 65 years; Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）; Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow; Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia; The score of Eastern Cooperative Oncology Group (ECOG) is 0-2; Renal function: creatinine clearance rate ≥ 30ml/min; Liver function: ALT<5 times normal value, bilirubin<3 times normal value; Predicted survival ≥ 3 months; Able to accept oral Venetoclax; Sign an informed consent form and be able to understand and follow the procedures required by this protocol.
Exclusion: Cardiac function < grade 2; Known human immunodeficiency virus (HIV) infection; Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment; Allergy to experimental drugs; Diagnosed of acute promyelocytic leukemia (AML-M3); Patients with central nervous system (CNS) invasion; Pregnant and lactating women; Patients who ineligible for the study according to the investigator's assessment.