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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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

Key facts

Study ID: NCT07023588
Run by: Yehui Tan
People needed: 70
Starts: 2025-06-01
Expected to finish: 2029-05-01
Last updated by the study team: 2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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. -

You may not qualify if…

Acute promyelocytic leukemia (APL).
Mixed phenotype acute leukemia (MPAL).
AML patients with known central nervous system (CNS) involvement.
Presence of extramedullary disease (EMD).
Significant hepatic or renal dysfunction exceeding the inclusion criteria limits.
Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction.
Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible).
Active tuberculosis or HIV-positive patients.
Concurrent other hematological disorders.
Pregnant or lactating women.
Inability to comprehend or comply with the study protocol.
Hypersensitivity to any component of the drugs involved in the protocol.
Inability to take oral medication or patients with malabsorption syndrome.
Uncontrolled systemic infection.
Prior venetoclax treatment and/or current participation in any other study involving investigational agents.

Where it is running

The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)

Full record on ClinicalTrials.gov

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