NCT06429098 Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
| NCT ID | NCT06429098 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-01-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥ 18 years. 2. Newly diagnosed CBFβ::MYH11(+) AML. 3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale. 4. 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: 1. Age\>75 years. 2. There are serious underlying heart, lung, kidney, liver complications. 3. There are active infections that do not respond to anti-infective therapy. 4. There is cognitive impairment. 5. Other comorbidities that the doctor determines are not suitable for intensive chemotherapy. Exclusion Criteria: 1. 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). 2. Pregnant or lactating women. 3. 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. 4. Other conditions deemed unsuitable for participation in this study by the investigator.
Contact & Investigator
Ying Wang
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06429098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06429098 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06429098 currently recruiting?
Yes, NCT06429098 is actively recruiting participants. Contact the research team at wangying77@suda.edu.cn for enrollment information.
Where is the NCT06429098 trial being conducted?
This trial is being conducted at Suzhou, China, Suzhou, China.
Who is sponsoring the NCT06429098 clinical trial?
NCT06429098 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Ying Wang at The First Affiliated Hospital of Soochow University. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.