Acute Myeloid LeukemiaPhase 2NCT07425782
Venetoclax Combined With Azacitidine for Consolidation Therapy in AML
A Phase 2 study testing Ara-C Group and VEN/AZA condsolidation in people with Acute Myeloid Leukemia and Consolidation Therapy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Consolidation Therapy, Venentoclax
- What is being tested?
- Ara-C Group and VEN/AZA condsolidation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 26 Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;
- Age ≥ 18 years;
- Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);
- Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;
- Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival > 8 weeks;
- Voluntarily signed the informed consent form and can understand and comply with study requirements.
Who cannot join
- Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;
- Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;
- Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
- Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;
- Pregnant or breastfeeding women;
- Inability to understand, comply with the study protocol, or sign the informed consent form;
- Any other conditions deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hosptital of Soochow University
Suzhou, Jiangsu, 215000
Qi Qu, +8651267976801, quqimedsz@163.com
About this study
Official title: A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Acute Myeloid Leukemia
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.
Read the detailed description
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.
- Conditions
- Acute Myeloid Leukemia, Consolidation Therapy, Venentoclax, High Risk, Hematopoietic Stem Cell Transplant (HSCT)
- Being tested
- Ara-C Group, VEN/AZA condsolidation
- Keywords
- Acute Myeloid Leukemia, Consolidation Therapy, Venentoclax, Allogenice Hematopoietic Stem Cell Transplantation, High risk
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ara-C GroupDrug
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.
VEN/AZA condsolidationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Ara-C Group |
| 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. Receives: Drug: VEN/AZA condsolidation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (4)
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.
Measured: From the end of the last consolidation therapy to the initiation of conditioning regimen for allogeneic hematopoietic stem cell transplantation, within approximately 1 month.
Overall survival
From the first day of randomization to the date of death from any cause
Measured: 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.
Measured: 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
Measured: From date of randomization until date of death without prior relapse or disease progression, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completion26 Nov 2028 (estimated)
- Study completion26 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN Jia, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425782
- Sponsor's protocol ID
- SZ3704
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No