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Acute Myeloid LeukemiaPhase 2/3NCT05356169

Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia

A Phase 2/3 study testing with or without venetoclax in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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

300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
with or without venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteChina
Study dates
19 May 2022to 15 Oct 2027
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

  • Patients with newly diagnosed AML (except for APL subtype) according to 2016 World Health Organization (WHO) classification and have not received chemotherapy before.
  • Age ≥18 years and ≤65 years.
  • Patient considered eligible for intensive chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at randomization.
  • Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
  • Adequate hepatic function as evidenced by:(1) Serum total bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN, unless considered due to leukemic involvement following approval by the Coordinating Investigator or Trial Coordinator;(3)Myocardial enzyme<2.0×upper limit normal;(4)Left ventricular ejection fraction are within the normal range by measure of echocardiogram (ECHO)
  • No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 25x109/L).
  • Able to understand and willing to sign an informed consent form (ICF).

Who cannot join

  • AML with BCR-ABL1; or myeloid blast crisis of CML.
  • Subjects who have received a prior treatment for AML with chemotherapy , hypomethylating agents or venetoclax before.
  • Subjects with acute panmyelosis with myelofibrosis or myeloid sarcoma defined by WHO 2016.
  • Subjects with a prior history of MDS, MPN or MDS/MPN.
  • Subjects with other concurrent malignant tumors on treatment with the exception of basal or squamous cell carcinoma of the skin,carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding of prostate cancerand need treatment.
  • Pregnant or lactating women.
Show all 12Show fewer
  • Active heart disease, defined as anyone of the followings:(1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
  • Subjects with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
  • Subjects with an active viral infection caused by HIV, hepatitis B or hepatitis C virus that cannot be controlled by treatment.
  • Subjects with evidence of central nervous system leukemia before treatment.
  • Subjects with epilepsy which needs drug treatment, dementia, or other abnormal mental state that can't understand or follow the protocol.
  • Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Phase 2/3 Prospective, Randomized, Controlled, Parallel Group Study of Intensive Therapy Combined With Venetoclax for Newly Diagnosed Adult Acute Myeloid Leukemia

300 patients will be randomly distributed into the control group (n=150) and the experimental group(n=150). Patients will receive two cycles of induction chemotherapy. The control group receives standard 3+7 induction regimen containing cytarabine (100mg/m2 d1-7) and daunorubicin (60mg/m2 d1-3). The experimental group receives venetoclax combined with intensive chemotherapy (3+7 induction regimen same as the control group). For each group, patients who fail to achieve CR/CRi after two courses of induction therapy may receive alternative therapy decided by their physicians. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks: subjects in favorable risk group should continue with chemotherapy; subjects in poor risk group should go through transplantation; for subjects in intermediate risk group, those with suitable donors can receive transplantation while others can continue with consolidation therapy. Subjects receive 3 courses of intermediate-dose cytarabine (1.5g/m2 q12h d1, 3, 5) for age>55 years or high dose cytarabine (3g/m2 q12h d1, 3, 5) for age≤ 55 years as consolidation therapy with venetoclax in experimental group and without venetoclax in control group. After consolidation, patients will be observed.

Being tested
with or without venetoclax
Keywords
acute myeloid leukemia, adult, newly diagnosed, venetoclax, intensive chemotherapy
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.

  • with or without venetoclaxDrug

    Bcl-2 inhibitor

Study groups in NCT05356169
Study groupRoleWhat they receive
Venetoclax combined with intensive chemotherapyExperimentalThe experimental group receives two cycles of inducation chemotherapy consisting of venetoclax combined with standard DA 3+7 regimen. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age>55 years）or high（for age≤ 55 years） dose cytarabine combined with venetoclax.
Receives: Drug: with or without venetoclax
Intensive chemotherapy onlyActive comparatorThe control group receives two cycles of inducation chemotherapy consisting of standard DA 3+7 regimen without venetoclax. After CR/CRi achieved, subjects proceed allo-transplantation or consolidation therapy according to their ELN risks. The consolidation chemotherapy regimen consists of three cycles of intermediate （for age>55 years）or high（for age≤ 55 years） dose cytarabine without venetoclax.
Receives: Drug: with or without venetoclax

What is being measured

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

  1. Event-free survival

    The time from randomization to treatment failure, death from any cause or relapse after achieving CR or CRi, whichever occurs first.

    Measured: up to 12 months

Secondary outcomes (6)

  1. Overall survival Overall survival

    The time from randomization to death resulting from any cause

    Measured: up to 36 months

  2. CR rate

    The proportion of patients achieving CR after two cycles of induction chemotherapy.

    Measured: up to 2 months

  3. Rates of remission (CR/CRi) without measurable residual disease (CRMRD-)

    The proportion of AML patients achieving CR/CRi with negativity for a genetic marker by real-time quantitative polymerase chain reaction and/or with negativity by multi-color flow cytometry.

    Measured: up to 2 months

  4. Relapse free survival

    From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day.

    Measured: up to 36 months

  5. Cumulative incidence of relapse

    Calculated from tdate of first CR to the date of relapse, considering nonrelapse mortality (NRM) as a competing event

    Measured: up to 36 months

  6. Frequency and severity of AEs

    Adverse clinical events in the course of drug treatment according to CTCAE v5.0.

    Measured: up to 8 months

Timeline

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

  1. First posted2 May 2022
  2. Study start19 May 2022
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 Oct 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05356169
Sponsor's protocol ID
IIT2021055
Status last verified
Feb 2025
First submitted
19 Apr 2022
Last updated
30 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing with or without venetoclax in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 inclusion and 12 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 30 May 2025. 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?

Event-free survival (time frame: up to 12 months). 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 NCT05356169.

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 30 May 2025.

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