Acute Myeloid LeukemiaNCT06066242
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
A study testing Different induction chemotherapy regimens in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Different induction chemotherapy regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 10 May 2028
- Phase
- Interventional
- 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
- Able to understand the study and voluntarily sign informed consent.
- Age: 60~75 years old, gender unlimited.
- Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
- Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
- Fit for intensive chemotherapy.
- The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound
Who cannot join
- Patients with acute promyelocytic leukemia
- Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
- Patients with BCR::ABL fusion gene
- Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
- Patients with concurrent malignant tumors requiring treatment
- Patients with active heart disease defined as one or more of the following: (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.
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Different induction chemotherapy regimens
- Keywords
- elderly, newly diagnosed, fit, induction regimen
- 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.
Different induction chemotherapy regimensOther
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
| Study group | Role | What they receive |
|---|---|---|
| AZA+VEN | Experimental | Azacitidine combined with venetoclax as induction regimen Receives: Other: Different induction chemotherapy regimens |
| DA/IA 3+7 | Active comparator | Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen Receives: Other: Different induction chemotherapy regimens |
| DA/IA 2+5+VEN | Experimental | Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen Receives: Other: Different induction chemotherapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
Measured: Up to approximately 2 years
Secondary outcomes (7)
30-day postinduction mortality
It is defined as death from any cause within 30 days after the start of induction.
Measured: Up to approximately 30 days
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Proportion of patients with CR, CRh or CRi
Measured: Up to approximately eight weeks
Minimal residual disease (MRD)-negative remission rates after induction
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative
Measured: Up to approximately eight weeks
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
The proportion of patients with negative MRD results at any time during treatment
Measured: Up to approximately 1 years
Relapse-free Survival (RFS)
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Measured: Up to approximately 2 years
Overall survival (OS)
It is defined as the time from the start of randomization to the death from any cause.
Measured: Up to approximately 2 years
60-day postinduction mortality
It is defined as death from any cause within 60 days after the start of induction.
Measured: Up to approximately 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Oct 2023
- Primary completion20 Oct 2027 (estimated)
- Study completion10 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wei, MD, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066242
- Sponsor's protocol ID
- IIT2023059
- Status last verified
- May 2026
- First submitted
- 27 Sep 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06066242
- Acronym / sponsor ID
- IIT2023059
- Conditions
- Acute Myeloid Leukemia
- Keywords
- elderly, newly diagnosed, fit, induction regimen
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 10 May 2028 (estimated)
- First posted
- 4 Oct 2023 (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.
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZA+VEN | Experimental | Other: Different induction chemotherapy regimensAzacitidine combined with venetoclax as induction regimen |
| DA/IA 3+7 | Active comparator | Other: Different induction chemotherapy regimensDaunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen |
| DA/IA 2+5+VEN | Experimental | Other: Different induction chemotherapy regimensDaunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand the study and voluntarily sign informed consent.
- Age: 60~75 years old, gender unlimited.
- Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
- Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
- Fit for intensive chemotherapy.
Key exclusion criteria (7 listed)
- Patients with acute promyelocytic leukemia
- Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
- Patients with BCR::ABL fusion gene
- Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
- Patients with concurrent malignant tumors requiring treatment
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 |
|---|---|---|
| Different induction chemotherapy regimensazacitidine combined with venetoclax or chemotherapy with or without venetoclax | Other | AZA+VEN, DA/IA 2+5+VEN, DA/IA 3+7 |
Primary outcome
Event-free survival (EFS)
Time frame: Up to approximately 2 years
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
7 secondary outcomes
30-day postinduction mortality
Time frame: Up to approximately 30 days
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Time frame: Up to approximately eight weeks
Minimal residual disease (MRD)-negative remission rates after induction
Time frame: Up to approximately eight weeks
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
Time frame: Up to approximately 1 years
Relapse-free Survival (RFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
60-day postinduction mortality
Time frame: Up to approximately 60 days
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 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hui Wei, MD principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different induction chemotherapy regimens 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 6 inclusion and 7 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 13 May 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.
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 (EFS) (time frame: Up to approximately 2 years). 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 13 May 2026.