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

Yehui Tan

Status and phase: Enrolling; Phase 2

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Venetoclax

Study type: Interventional

Funder types: Other

Identifiers

NCT07023588

2025-HS-002

Details and patient eligibility

About

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

Full description

This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

venetoclax，8-14d

Experimental group

Treatment:

Drug: Venetoclax

Control group

No Intervention group