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Clinical Trials in China / NCT07023588
Recruiting Phase 2

Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease

NCT07023588 · tracked via the Priya Life Science China tracker
Sponsor
Yehui Tan
Phase
Phase 2
Started
2025-06-01
Last updated
2025-08-08

Condition(s) studied

Acute Myeloid Leukemia (AML)

Investigational drug(s) / intervention(s)

Venetoclax →

Venetoclax: Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping. 2. Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%. 6. Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection). 7. 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). 8. Patients deemed suitable to receive DA/IA therapy by the investigator. 9. Signed informed consent form. - Exclusion Criteria: 1. Acute promyelocytic leukemia (APL). 2. Mixed phenotype acute leukemia (MPAL). 3. AML patients with known central nervous system (CNS) involvement. 4. Presence of extramedullary disease (EMD). 5. Significant hepatic or renal dysfunction exceeding the inclusion criteria limits. 6. Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction. 7. Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible). 8. Active tuberculosis or HIV-positive patients. 9. Concurrent other hematological disorders. 10. Pregnant or lactating women. 11. Inability to comprehend or comply with the study protocol. 12. Hypersensitivity to any component of the drugs involved in the protocol. 13. Inability to take oral medication or patients with malabsorption syndrome. 14. Uncontrolled systemic infection. 15. Prior venetoclax treatment and/or current participation in any other study involving investigational agents.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More Yehui Tan trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023588 on ClinicalTrials.gov ↗ ← All trials in China