NCT06429098Active, not recruitingPhase 2
Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
Study of A Venetoclax-based, Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβ::MYH11-positive Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 14 May 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06429098
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Jan 2024 to the primary completion date, 30 Jun 2027
- 2 sites 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.
Other illness
- Other conditions deemed unsuitable for participation in this study by the investigator.
Lab values
- Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell count).
Other
- Pregnant or lactating women.
- To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the required study procedures.
Who the study is looking for
- Adults ≥ 18 years.
- Newly diagnosed CBFβ::MYH11(+) AML.
- Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures.
- Ferrara's criteria are used to determine whether a patient is unfit, and a patient is deemed unfit if at least one of the following criteria is met:
- Age\>75 years.
- There are serious underlying heart, lung, kidney, liver complications.
- There are active infections that do not respond to anti-infective therapy.
- There is cognitive impairment.
- Other comorbidities that the doctor determines are not suitable for intensive chemotherapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Ethical Committee of the First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.