Tests venetoclax treatment timing in adults with acute myeloid leukemia
Tests venetoclax in adults with acute myeloid leukemia, guided by early blood residual disease.
Plain-language title generated from the registry record
Registry title: Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
Key facts
- Where
- Changchun, 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 adults with newly diagnosed acute myeloid leukemia who still have at least 1% blasts (immature leukemia cells) in the blood on day 6 of treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed acute myeloid leukemia (AML), confirmed by bone marrow tests, with full lab work-up done. Blasts in the blood on day 6 must be 1% or more. Daily activity level (ECOG) 0-2.
- Earlier treatment
- People who have had venetoclax before cannot join. The investigator must judge the person able to receive DA/IA chemotherapy.
- Biomarker or test result
- Blood blast percentage on day 6 of 1% or more. Kidney function: creatinine clearance 50 mL/min or more. Liver tests: AST and ALT up to 2.5 times the upper limit of normal, total bilirubin up to 1.5 times the upper limit of normal (unless caused by the leukemia).
Main reasons for not taking part
- Acute promyelocytic leukemia or mixed phenotype acute leukemia
- Leukemia in the central nervous system or outside the bone marrow
- Severe heart disease
- Active tuberculosis or HIV-positive
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Where in China
- The First Hospital of Jilin UniversityChangchun, ChinaContact: Yehui TanTaking people
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
- Yehui Tan
- Trial code
- NCT07023588
- Record updated
- 8 August 2025
- Original description
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual diseaseRead full original descriptionShow less
A Multicenter, Open-label, Prospective, Randomized Controlled Study to Optimize the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
Inclusion: Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping; Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up; Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%; Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection); Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN*; Total bilirubin ≤ 1.5 × ULN* (*Unless considered due to leukemia infiltration); Patients deemed suitable to receive DA/IA therapy by the investigator; Signed informed consent form. -.
Exclusion: Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible); Concurrent other hematological disorders; Prior venetoclax treatment and/or current participation in any other study involving investigational agents; Presence of extramedullary disease (EMD); Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction; Active tuberculosis or HIV-positive patients; Hypersensitivity to any component of the drugs involved in the protocol; Inability to take oral medication or patients with malabsorption syndrome; Uncontrolled systemic infection; Acute promyelocytic leukemia (APL); Mixed phenotype acute leukemia (MPAL); AML patients with known central nervous system (CNS) involvement; Significant hepatic or renal dysfunction exceeding the inclusion criteria limits; Pregnant or lactating women; Inability to comprehend or comply with the study protocol.