NCT07672262 VA Consolidation in Intermediate-Risk AML
| NCT ID | NCT07672262 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2030-06-01 |
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.
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 226 participants in total. It began in 2026-06-01 with a primary completion date of 2030-06-01.
⚠ 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 clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria; * Age ≥ 18 years; * Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification; * Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy; * Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT); * ECOG performance status score 0 to 2 * Adequate organ function: creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \> 8 weeks * Voluntarily signed informed consent form and able to comply with study requirements Exclusion Criteria: * Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months) * Active central nervous system (CNS) leukemia or extramedullary infiltration * Other serious diseases limiting participation (e.g., severe infection, renal failure) * Known HIV infection or uncontrolled severe viral hepatitis * Pregnant or breastfeeding women * Inability to understand, comply with protocol, or sign informed consent * Any other conditions deemed unsuitable by the investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07672262 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 NCT07672262 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 NCT07672262 currently recruiting?
Yes, NCT07672262 is actively recruiting participants. Contact the research team at quqimedsz@163.com for enrollment information.
Where is the NCT07672262 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07672262 clinical trial?
NCT07672262 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 226 participants.
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