Optimizing AML treatment using early peripheral blood minimal residual disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, randomized controlled Phase 2 trial led by The First Hospital of Jilin University that enrolls adults with newly diagnosed AML who have Day 6 peripheral blood blasts meeting the protocol threshold. Eligible participants are randomized to receive standard induction chemotherapy with or without the addition of venetoclax, with approximately 70 subjects planned (35 per arm). The study collects baseline demographics, disease and treatment details, safety data, and outcome measures including response and relapse, and performs statistical comparisons of efficacy and safety between arms. The protocol uses early peripheral blood minimal residual disease (MRD) measurements to select patients with suboptimal early response for the intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Yehui Tan
• Email: yhtan@jlu.edu.cn
• Phone: 8615948027438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.