Acute Myeloid Leukemia (AML)Phase 3NCT06990321
Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
A Phase 3 study testing Intermediate-dose Cytarabine in Combination with Venetoclax in people with Acute Myeloid Leukemia (AML) and Elderly, run by Yehui Tan at 1 site in China.
Trial summary
A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Elderly
- What is being tested?
- Intermediate-dose Cytarabine in Combination with Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Phase 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment):
- Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
- AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
- Serum creatinine \< 2 times the upper limit of normal for the same age group;
- Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications.
Who cannot join
- Subjects who meet any of the following criteria shall not be included in this study:
- Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.
- Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
- Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
- Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
- Known or suspected drug abuse or alcohol dependence.
Show all 11Show fewer
- Mental illness or any condition that prevents obtaining informed consent, or inability to comply with the study treatment and examination requirements.
- Liver dysfunction (total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN, or liver-involved patients with ALT/AST \>5×ULN), kidney dysfunction (serum creatinine \>1.5×ULN).
- Active heart disease, defined as one or more of the following:
- 1) History of uncontrolled or symptomatic angina. 2) Myocardial infarction within 6 months prior to enrollment. 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms.
- 4) Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2). 5) Ejection fraction below the lower limit of normal. 9.Participation in another clinical trial within 30 days. 10.Active infection. 11.The investigator deems the subject unfit for participation in this trial.
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 Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination With Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in The Elderly
A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly
Read the detailed description
This study is designed to be a prospective cohort study conducted at the First Hospital of Jilin University. The target populations of this study are patients with Middle- and High-risk Acute Myeloid Leukemia in the elderly who received intermediate-dose cytarabine in combination with venetoclax for consolidation therapy from June 1, 2025to December 31, 2026. It is expected to enroll 68 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures
- Conditions
- Acute Myeloid Leukemia (AML), Elderly
- Being tested
- Intermediate-dose Cytarabine in Combination with 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.
Intermediate-dose Cytarabine in Combination with VenetoclaxDrug
Elderly patients with Middle- and High-risk Acute Myeloid Leukemia who received the Intermediate-dose Cytarabine in Combination with Venetoclax at the First Hospital of Jilin University from March 1, 2024 to December 31, 2026.
| Study group | Role | What they receive |
|---|---|---|
| Middle-and High-risk Acute Myeloid Leukemia in the Elderly | Experimental | Not described Receives: Drug: Intermediate-dose Cytarabine in Combination with Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 36 months.
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 36 months.
Cumulative Relapse Rate (CIR)
Defined as the proportion of patients who experience disease relapse from the time of enrollment in this study.
Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
MRD Negative Conversion Rate
Defined as the proportion of patients who convert to MRD negative among all evaluable patients for efficacy.
Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 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
- NCT06990321
- Sponsor's protocol ID
- 2024-HS-084
- Status last verified
- Aug 2025
- First submitted
- 18 May 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 Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination With Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in The Elderly
- ClinicalTrials.gov ID
- NCT06990321
- Acronym / sponsor ID
- 2024-HS-084
- Conditions
- Acute Myeloid Leukemia (AML), Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Yehui TanUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 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 Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly
Detailed description
This study is designed to be a prospective cohort study conducted at the First Hospital of Jilin University. The target populations of this study are patients with Middle- and High-risk Acute Myeloid Leukemia in the elderly who received intermediate-dose cytarabine in combination with venetoclax for consolidation therapy from June 1, 2025to December 31, 2026. It is expected to enroll 68 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle-and High-risk Acute Myeloid Leukemia in the Elderly | Experimental | Drug: Intermediate-dose Cytarabine in Combination with Venetoclax |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment):
- Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;
- AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;
- Serum creatinine \< 2 times the upper limit of normal for the same age group;
- Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications.
Key exclusion criteria (11 listed)
- Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.
- Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.
- Hematologic relapse (bone marrow blasts or immature cells exceed 5%).
- Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).
- Known or suspected drug abuse or alcohol dependence.
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 |
|---|---|---|
| Intermediate-dose Cytarabine in Combination with VenetoclaxElderly patients with Middle- and High-risk Acute Myeloid Leukemia who received the Intermediate-dose Cytarabine in Combination with Venetoclax at the First Hospital of Jilin University from March 1, 2024 to December 31, 2026. | Drug | Middle-and High-risk Acute Myeloid Leukemia in the Elderly |
Primary outcome
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 36 months.
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
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 36 months.
Cumulative Relapse Rate (CIR)
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
MRD Negative Conversion Rate
Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 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.
Related trials for Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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 3 study testing Intermediate-dose Cytarabine in Combination with Venetoclax in people with Acute Myeloid Leukemia (AML) and Elderly, 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 5 inclusion and 11 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 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?
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?
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 36 months.). 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.