NCT07490288 Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
| NCT ID | NCT07490288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2026-05-08 with a primary completion date of 2026-07-01.
⚠ 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 is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow) * Age ≥ 14 years, male or female. * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. * Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment): i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group. ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \< 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \< 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO). Exclusion Criteria: * Acute promyelocytic leukemia with PML::RARA fusion gene. * Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene. * Acute myeloid leukemia with BCR::ABL1 fusion gene. * Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed). * Concurrent active malignancy of other organs (requiring treatment). * Active cardiac disease, defined as one or more of the following: i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms. iv. Uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] Class 2). * Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07490288 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 100 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07490288 currently recruiting?
Yes, NCT07490288 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT07490288 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07490288 clinical trial?
NCT07490288 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 27 participants.