NCT07023588RecruitingPhase 2
Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
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
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 8 Jun 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- Yehui Tan
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07023588
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 1 Jun 2025 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible).
- Concurrent other hematological disorders.
- Prior venetoclax treatment and/or current participation in any other study involving investigational agents.
Other illness
- Presence of extramedullary disease (EMD).
- Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction.
- Active tuberculosis or HIV-positive patients.
- Hypersensitivity to any component of the drugs involved in the protocol.
- Inability to take oral medication or patients with malabsorption syndrome.
- Uncontrolled systemic infection.
Other
- Acute promyelocytic leukemia (APL).
- Mixed phenotype acute leukemia (MPAL).
- AML patients with known central nervous system (CNS) involvement.
- Significant hepatic or renal dysfunction exceeding the inclusion criteria limits.
- Pregnant or lactating women.
- Inability to comprehend or comply with the study protocol.
Who the study is looking for
- 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. -
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.