AML (Acute Myelogenous Leukemia)Phase 2/3NCT07537257

VEN+IDAC vs IDAC in AML

A Phase 2/3 study testing Ventoclax and Cytarabine in people with AML (Acute Myelogenous Leukemia), run by Guangdong Second Provincial General Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: AML (Acute Myelogenous Leukemia)
What is being tested?: Ventoclax and Cytarabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 232 participants
Where: 1 siteChina
Study dates: 1 Apr 2026to 1 Apr 2029
Phase: Phase 2/3

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 65 years, any gender;
Meet the WHO 2022 diagnostic criteria for acute myeloid leukemia (AML), and achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction therapy. CR is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥1.0×10⁹/L, and platelets ≥100×10⁹/L; CRi is defined as bone marrow blasts ≤5%, absolute neutrophil count ≥0.5×10⁹/L, and platelets ≥50×10⁹/L;
Baseline MRD testing (using multiparameter flow cytometry, MFC) must be completed at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
Major organ function is basically normal and meets the following requirements: ① Liver function: total bilirubin ≤1.5×ULN (except patients with liver metastasis or Gilbert's syndrome), ALT and AST ≤2.5×ULN; ② Kidney function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min; ③ Cardiac function: left ventricular ejection fraction (LVEF) ≥50%;
The patient or their legal representative signs a written informed consent form, agrees to comply with the study protocol, and completes the specified follow-up procedures.

Who cannot join

Presence of other active malignant tumors (excluding indolent tumors that have been cured, such as basal cell carcinoma of the skin and carcinoma in situ of the cervix);
Central nervous system leukemia;
Existence of uncontrolled severe infection (such as sepsis, fungal pneumonia, active tuberculosis, etc.);
History of severe heart disease, including but not limited to: severe arrhythmias (such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, etc.), history of myocardial infarction (within the past 6 months), severe heart failure (NYHA functional class ≥3), etc.;
Women who are pregnant or breastfeeding; women planning pregnancy or men of reproductive potential who have not used effective contraception during the study and within 6 months after treatment;
Known allergy to venetoclax, cytarabine, or other components of the combination regimen in the study;

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Having mental illness (such as schizophrenia, major depressive disorder, etc.) or cognitive dysfunction that prevents cooperation with study follow-up and treatment;
Active hepatitis B virus infection (HBV DNA positive), active hepatitis C virus infection (HCV RNA positive), or human immunodeficiency virus (HIV) infection;
Undergoing major surgery, radiation therapy, other chemotherapy drugs, or investigational drug treatments within 3 weeks prior to study drug treatment.

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

Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong

Other trials in China

About this study

Official title: Venetoclax Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine for Consolidation Therapy of Acute Myeloid Leukemia (AML): a Multicenter, Prospective, Randomized Controlled, Phase 2 Study

Read the detailed description

Studies have shown that venetoclax can significantly enhance the efficacy of intensive chemotherapy (IC) in the induction and salvage treatment of AML. However, there is still a lack of direct comparison of the efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) with IDAC for consolidation in AML. In order to evaluate the benefit of venetoclax combined with IDAC, we plan to conduct a multicenter, prospective randomized controlled, phase 2 study to compare the efficacy and safety of venetoclax (d1-7, 400mg QD) combined with cytarabine (d1-3, 1.5g/㎡, q12h) versus cytarabine only for consolidation therapy in AML, aiming to fill the current evidence gap and provide scientific basis for improving deeper remission of AML and finally improve patients' long-term survival.

Conditions: AML (Acute Myelogenous Leukemia)
Being tested: Ventoclax, Cytarabine
Keywords: Acute myeloid leukemia, Venetoclax, Cytarabine, Consolidation, Measurable residual disease
Medical subject headings: Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VentoclaxDrug
Venetoclax 400mg per day from day 1 to day 7
CytarabineDrug
Cytarabine 1.5g/m^2 q12h from day 1 to day 3.

Study groups in NCT07537257
Study group	Role	What they receive
VEN+IDAC	Experimental	Venetoclax 400mg per day from day 1 to day 7; cytarabine 1.5g/m^2 q12h from day 1 to day 3. Receives: Drug: Ventoclax; Drug: Cytarabine
IDAC	Active comparator	Cytarabine 1.5g/m^2 q12h from day 1 to day 3 Receives: Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Measurable residual disease (MRD) negative
MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%.
Measured: At the end of cycle 2 (28 days for a cycle)

Secondary outcomes (5)

Cumulative Incidence of Recurrence (CIR)
Assess the risk of leukemia recurrence after the consolidation
Measured: 2 years
Overall survival (OS)
OS is calculated from enrollment to death or the last follow-up.
Measured: 2 years
Disease Free Survival (DFS)
It refers to the time from the start of the consolidation to disease recurrence or death from any cause or the last follow-up.
Measured: 2 years
Aderse events
Side effects of the consolidations including haematological and non-haematological toxicity.
Measured: At the end of cycle 2 (28 days for a cycle)
The rate of being bridged to allogeneic hematopoietic stem cell transplantation
To assess how many patients are needed to accept allogeneic hematopoietic stem cell transplantation after the consolidation.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20261 Apr 2029

First posted17 Apr 2026
Study start1 Apr 2026 (estimated)
Primary completion1 Apr 2027 (estimated)
Study completion1 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AML (Acute Myelogenous Leukemia)Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 232 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07537257
Sponsor's protocol ID: GD2H-2026-481
Status last verified: Apr 2026
First submitted: 3 Apr 2026
Last updated: 17 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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