Acute Myeloid Leukemia (AML)Phase 2NCT07023588
Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
A Phase 2 study testing Venetoclax in people with Acute Myeloid Leukemia (AML), run by Yehui Tan at 1 site in China.
Trial summary
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to May 2029
- 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
- Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping.
- Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%.
- Renal function with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection).
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- Liver function with Aspartate Aminotransferase (AST) ≤ 2.5 × ULN*; Alanine Aminotransferase (ALT) ≤ 2.5 × ULN*; Total bilirubin ≤ 1.5 × ULN* (*Unless considered due to leukemia infiltration).
- Patients deemed suitable to receive DA/IA therapy by the investigator.
- Signed informed consent form. -
Who cannot join
- Acute promyelocytic leukemia (APL).
- Mixed phenotype acute leukemia (MPAL).
- AML patients with known central nervous system (CNS) involvement.
- Presence of extramedullary disease (EMD).
- Significant hepatic or renal dysfunction exceeding the inclusion criteria limits.
- Severe cardiac disease, including congestive heart failure, myocardial infarction, or cardiac dysfunction.
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- Concurrent active malignancy of other organ systems (patients with a history of cured malignancy may be eligible).
- Active tuberculosis or HIV-positive patients.
- Concurrent other hematological disorders.
- Pregnant or lactating women.
- Inability to comprehend or comply with the study protocol.
- Hypersensitivity to any component of the drugs involved in the protocol.
- Inability to take oral medication or patients with malabsorption syndrome.
- Uncontrolled systemic infection.
- Prior venetoclax treatment and/or current participation in any other study involving investigational agents.
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 Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: A Multicenter, Open-label, Prospective, Randomized Controlled Study to Optimize the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
Read the detailed description
This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Venetoclax
- 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
Patients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| venetoclax，8-14d | Experimental | Not described Receives: Drug: Venetoclax |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Composite Complete Response Rate（mCRc）
Complete Response（CR） + Complete Response with Incomplete Hematologic Recovery（CRi）+Morphologic Leukemia Free State（MLFS）
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Overall Survival (OS)
Defined as the time from enrollment in this study to death from any cause. If the exact date of death is unknown, the time of death is defined as the last contact date. If the patient is still alive, the last observed time will be used, and the patient's OS will be considered for analysis.
Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
MRD Negative Conversion Rate
Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.
Measured: Through study completion, an average of 1 year
Relapse-Free Survival(RFS)
Defined as the time from enrollment in this study to the occurrence of relapse. For patients without relapse, the time is calculated until death from any cause or the time of the last follow-up
Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jun 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yehui Tan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yehui Tan, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023588
- Sponsor's protocol ID
- 2025-HS-002
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Prospective, Randomized Controlled Study to Optimize the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT07023588
- Acronym / sponsor ID
- 2025-HS-002
- Conditions
- Acute Myeloid Leukemia (AML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yehui TanUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label, prospective, randomized controlled study to optimize the treatment of patients with acute myeloid leukemia based on early peripheral blood minimal residual disease
Detailed description
This study is a randomized controlled, prospective clinical trial, with the leading unit being the First Hospital of Jilin University. It aims to screen patients with a suboptimal response to chemotherapy based on early peripheral blood minimal residual disease (MRD) levels, and explore the efficacy and safety of adding venetoclax. A total of 70 subjects are expected to be enrolled, with 35 subjects each in the experimental group and the control group. The study will collect data on subjects' demographics, other baseline characteristics, medication usage, prognosis, etc. Statistical analysis will be performed on the collected data to compare efficacy indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venetoclax，8-14d | Experimental | Drug: Venetoclax |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed AML patients confirmed by bone marrow morphology and immunophenotyping.
- Complete MICM (Morphology, Immunophenotyping, Cytogenetics, Molecular genetics) work-up.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Day 6 Peripheral Blood Blast Percentage (D6PBBP) ≥ 1%.
Key exclusion criteria (15 listed)
- Acute promyelocytic leukemia (APL).
- Mixed phenotype acute leukemia (MPAL).
- AML patients with known central nervous system (CNS) involvement.
- Presence of extramedullary disease (EMD).
- Significant hepatic or renal dysfunction exceeding the inclusion criteria limits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxPatients identified with a suboptimal response to chemotherapy based on minimal residual disease (MRD) levels in peripheral blood on Day 6 will initiate venetoclax therapy added on Day 8, administered for 7 days. | Drug | venetoclax，8-14d |
Primary outcome
Modified Composite Complete Response Rate（mCRc）
Time frame: Through study completion, an average of 1 year
Complete Response（CR） + Complete Response with Incomplete Hematologic Recovery（CRi）+Morphologic Leukemia Free State（MLFS）
3 secondary outcomes
Overall Survival (OS)
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
MRD Negative Conversion Rate
Time frame: Through study completion, an average of 1 year
Relapse-Free Survival(RFS)
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 48 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax in people with Acute Myeloid Leukemia (AML), run by Yehui Tan 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Aug 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 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?
Contact Yehui Tan (8615948027438, yhtan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Composite Complete Response Rate（mCRc） (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.