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The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation.
The main questions it aims to answer are:
Does consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.
Background and Rationale:Current AML frontline therapy is shifting from intensive chemotherapy toward precision-based approaches. Venetoclax combined with hypomethylating agents (e.g., azacitidine) has become the standard of care for older or chemotherapy-ineligible patients and has shown comparable efficacy and improved safety in younger, fit patients compared with intensive chemotherapy.Pre-transplant consolidation remains a critical phase for reducing relapse risk; however, conventional cytarabine-based regimens are associated with high relapse rates. To date, no prospective studies have investigated venetoclax-based consolidation in AML. This trial aims to address this gap and provide evidence to guide post-remission therapy.
Study Design and Interventions:Eligible patients (aged ≥18 years) with newly diagnosed high-risk AML who achieved CR/CRi after 1-2 cycles of venetoclax plus azacitidine induction will be randomized 1:1 to:Experimental arm: Venetoclax-based consolidation regimen (per protocol)；Comparator arm: Conventional intermediate-dose cytarabine consolidation (per protocol).All patients will proceed to allo-HSCT after 1-2 consolidation cycles.
Endpoints:Primary: Leukemia-free survival (LFS). Key Secondary: MRD-negative rate before transplantation, overall survival (OS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), and safety profile.
Significance:This study will provide high-level evidence to guide consolidation strategies for high-risk AML in the venetoclax era, with the goal of improving transplant outcomes and long-term survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ara-C Consolidation Arm | Active Comparator | AraC (Cytarabine) 1-2 g/m², administered intravenously every 12 hours on days 1-3, may be combined with anthracycline/anthraquinone agents. After completing 1-2 cycles of consolidation therapy, the patient proceeds to allogeneic hematopoietic stem cell transplantation (allo-HSCT). |
|
| VA Consolidation Chemotherapy Arm | Experimental | VEN: 400 mg, orally, days 1-28 (Venetoclax dosage must be adjusted per prescribing information/guidelines based on concomitant use of CYP3A4 inhibitors); AZA: 75 mg/m²/day, subcutaneously, days 1-7; Proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) after completing 1-2 cycles of consolidation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ara-C Group | Drug | Ara-C 1-2 g/m², every 12 hours, intravenous infusion, days 1-3; may be combined with anthracyclines/anthraquinones, followed by allo-HSCT after consolidation within 2 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Leukemia free survival | Time from date of achieving complete remission until date of first documented hematologic relapse, extramedullary relapse, or death from any cause, whichever occurs first. | From date of complete remission until the date of first documented relapse or date of death from any cause, whichever came first, assessed up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Pretransplantation MRD negative rate | Proportion of patients who achieve minimal residual disease (MRD) negativity prior to hematopoietic stem cell transplantation, as assessed by multicolor flow cytometry, measured from bone marrow samples. | From the end of the last consolidation therapy to the initiation of conditioning regimen for allogeneic hematopoietic stem cell transplantation, within approximately 1 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Qu | Contact | +86 051267976801 | quqimedsz@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hosptital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| VEN/AZA condsolidation | Drug | Venetoclax 400 mg, orally, days 1-28 (the dose of Venetoclax should be adjusted according to the drug dosage instructions/guidelines when combined with CYP3A4 inhibitors); AZA: Azacitidine 75 mg/m² per day, subcutaneous injection, days 1-7. Patients will proceed to allo-HSCT after consolidation within 2 cycles. |
|
| Overall survival | From the first day of randomization to the date of death from any cause | From the first day of randomization to the date of death, assesed up to 2 years. |
| Cumulative relapse rate | From the date of achieving remission to the date of hematologic relapse. | From date of achieving remission to the date of death from any cause, assessed up to 2 years. |
| Non-relapse mortality | The proportion of patients who died from causes unrelated to disease relapse/progression after achieving remission or receiving an intervention | From date of randomization until date of death without prior relapse or disease progression, assessed up to 2 years. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |