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

Launched by YEHUI TAN · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve treatment for people with acute myeloid leukemia (AML), a type of blood cancer. The researchers want to see if checking for tiny amounts of leukemia cells in the blood early in treatment can help guide and personalize therapy to make it more effective. The study will compare different treatment approaches based on these early test results to find the best option for patients.

Adults aged 18 and older who have just been diagnosed with AML and meet certain health criteria may be eligible to join. Participants need to have a specific level of leukemia cells in their blood early on in treatment and be healthy enough to receive standard chemotherapy. The study will not include people with certain types of leukemia, serious heart, liver, or kidney problems, or other active infections or cancers. If you join, you will receive treatment and monitoring according to the study plan, and your doctors will use early blood tests to help decide the best treatment steps. This study is not yet open for enrollment but aims to find better ways to treat AML by tailoring therapy based on early test results.

Gender

ALL

Eligibility criteria

• 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.