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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
Are there results?
Not yet: the study is under way

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

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 evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.

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.

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 groupRoleWhat they receive
VEN+IDACExperimentalVenetoclax 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
IDACActive comparatorCytarabine 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.

  1. 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)

  1. Cumulative Incidence of Recurrence (CIR)

    Assess the risk of leukemia recurrence after the consolidation

    Measured: 2 years

  2. Overall survival (OS)

    OS is calculated from enrollment to death or the last follow-up.

    Measured: 2 years

  3. 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

  4. 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)

  5. 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. First posted17 Apr 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Measurable residual disease (MRD) negative (time frame: At the end of cycle 2 (28 days for a cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07537257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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