NCT07132684 Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
| NCT ID | NCT07132684 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-08-31 |
| Primary Completion | 2027-08-30 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2025-08-31 with a primary completion date of 2027-08-30.
⚠ 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 study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of AML according to WHO (2022) or ICC criteria. * Age ≥55 and ≤75 years. * ECOG performance status score of 0-2. * Adequate organ function: * Total bilirubin ≤1.5× upper limit of normal (ULN) * AST and ALT ≤2.5× ULN * Serum creatinine \<2× ULN * Cardiac enzymes \<2× ULN * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative. Exclusion Criteria: * Acute promyelocytic leukemia with PML-RARA fusion gene. * AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes. * AML with BCR-ABL fusion gene. * Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed). * Concurrent other malignancies requiring treatment. * Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal). * Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Other conditions deemed unsuitable by the investigator.
Contact & Investigator
Hui Wei, MD
PRINCIPAL INVESTIGATOR
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Frequently Asked Questions
Who can join the NCT07132684 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 75 Years, studying AML, Adult. 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 NCT07132684 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT07132684 currently recruiting?
Yes, NCT07132684 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT07132684 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07132684 clinical trial?
NCT07132684 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Hui Wei, MD at Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 240 participants.