Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
NCT ID: NCT07023588
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2025-06-01
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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venetoclax，8-14d
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.
Control group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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. -
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.
Exclusion Criteria
2. Mixed phenotype acute leukemia (MPAL).
3. AML patients with known central nervous system (CNS) involvement.
4. Presence of extramedullary disease (EMD).
18 Years
ALL
No
Sponsors
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Yehui Tan
OTHER
Responsible Party
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Yehui Tan
Professor
Locations
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The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Other Identifiers
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2025-HS-002
Identifier Type: -
Identifier Source: org_study_id
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