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Acute Myeloid LeukemiaPhase 2NCT06429098

Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML

A Phase 2 study testing Venetoclax, azacitidine and decitabine in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Venetoclax, azacitidine and decitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
1 Jan 2024to 31 Dec 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥ 18 years.
  • Newly diagnosed CBFβ::MYH11(+) AML.
  • Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures.
  • Ferrara's criteria are used to determine whether a patient is unfit, and a patient is deemed unfit if at least one of the following criteria is met:
  • Age>75 years.
Show all 10Show fewer
  • There are serious underlying heart, lung, kidney, liver complications.
  • There are active infections that do not respond to anti-infective therapy.
  • There is cognitive impairment.
  • Other comorbidities that the doctor determines are not suitable for intensive chemotherapy.

Who cannot join

  • Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell count).
  • Pregnant or lactating women.
  • To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the required study procedures.
  • Other conditions deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Ethical Committee of the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Study of A Venetoclax-based, Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβ::MYH11-positive Acute Myeloid Leukemia

This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.

Read the detailed description

Primary Objectives:

To determine the CR (complete remission) / CRi (complete remission with incomplete blood count recovery) rate of 2 cycles of VEN/HMA in patients with newly diagnosed (ND) CBFβ::MYH11-positive acute myeloid leukemia(AML).

Secondary Objectives:

  1. To determine the overall response rate (ORR) of 2 cycles of VEN/HMA in patients with ND CBFβ::MYH11-positive AML.
  2. To determine the safety of the combination regimen.
  3. To study the trajectories of molecular measurable residual disease (MRD) during the therapy.
  4. To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen.
  5. To assess the duration of response, overall survival (OS) and event free survival (EFS) of patients.

OUTLINE:

INDUCTION:

Patients with newly diagnosed CBFβ::MYH11(+) AML receive 2 cycles of VEN/HMA as induction therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously (SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5.

CONSOLIDATION:

Patient fitness will be reassessed according to the Ferrara criteria if CR or CRi is achieved after 2 cycles of VEN/HMA. Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3) combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA until disease progression.

After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Keywords
venetoclax, acute myeloid leukemia
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.

  • VenetoclaxDrug

    Also called ABT-199, ABT199, Venclexta

    Given PO, once daily. Treatment in cycle 1, the dose is 100 mg on day 1, then ramp up to 400mg. In all subsequent cycles, the dose of venetoclax is initiated at 400 mg daily.

  • azacitidineDrug

    Also called 5 AZC, 5-AZC

    Given SC

  • decitabineDrug

    Also called Dacogen

    Given IV

  • CytarabineDrug

    Also called 1-.beta.-Cytosine arabinoside, Ara-C

    Given IV

Study groups in NCT06429098
Study groupRoleWhat they receive
Venetoclax, Azacitidine/Decitabine/, CytarabineExperimentalINDUCTION: Patients receive 2 cycles of VEN/HMA as induction therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously (SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5. CONSOLIDATION: Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3) combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA until disease progression.
Receives: Drug: Venetoclax; Drug: azacitidine; Drug: decitabine; Drug: Cytarabine

What is being measured

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

  1. composite complete remission rate

    CR/CRi rate will be determined.

    Measured: after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).

Secondary outcomes (7)

  1. Overall response rate (ORR)

    ORR will be determined.

    Measured: after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).

  2. Incidence of adverse events

    Safety profile based on NCI CTCAE version 5.0 will be determined.

    Measured: From the start of treatment until death or last follow-up, assessed for up to 3 years.

  3. measurable residual disease (MRD) negativity

    MRD will be assessed by real-time qRCR.

    Measured: From the start of treatment until death or last follow-up, assessed for up to 3 years.

  4. Impact of concurrent gene mutations

    The impact of concurrent gene mutations ( analysis via an 81-gene institutional next-generation sequencing platform) on response and the survival of the combination regimen will be assessed.

    Measured: Baseline

  5. Overall survival (OS)

    OS will be assessed.

    Measured: From the start of treatment until death or last follow-up, assessed for up to 3 years.

  6. Event-free survival (EFS)

    EFS will be assessed.

    Measured: up to 3 years.

  7. Duration of response (DOR)

    DOR will be assessed.

    Measured: up to 3 years.

Timeline

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

  1. First posted24 May 2024
  2. Study start1 Jan 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429098
Sponsor's protocol ID
2023371
Status last verified
Aug 2026
First submitted
14 May 2024
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax, azacitidine and decitabine in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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.

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?

composite complete remission rate (time frame: after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).). 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 NCT06429098.

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 9 Sep 2026.

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