AML, AdultPhase 3NCT07132684
Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
A Phase 3 study testing Daunorubicin/Idarubicin, Cytarabine and Azacitidine in people with AML, Adult, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- AML, Adult
- What is being tested?
- Daunorubicin/Idarubicin, Cytarabine and Azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 30 Aug 2028
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AML according to WHO (2022) or ICC criteria.
- Age ≥55 and ≤75 years.
- ECOG performance status score of 0-2.
- Adequate organ function:
- Total bilirubin ≤1.5× upper limit of normal (ULN)
- AST and ALT ≤2.5× ULN
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- Serum creatinine <2× ULN
- Cardiac enzymes <2× ULN
- Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.
Who cannot join
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
- Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
- Concurrent other malignancies requiring treatment.
- Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
- Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
- Other conditions deemed unsuitable by the investigator.
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
Blood Diseases Hospital
Tianjin
Hui Wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
- Conditions
- AML, Adult
- Being tested
- Daunorubicin/Idarubicin, Cytarabine, Azacitidine, Venetoclax
- Keywords
- acute myeloid leukemia, Older fit patients, 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.
Daunorubicin/IdarubicinDrug
Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.
CytarabineDrug
Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.
AzacitidineDrug
Azacitidine is used in VA regimen
VenetoclaxDrug
Venetoclax is used in VA regimen
| Study group | Role | What they receive |
|---|---|---|
| D/IA (Daunorubicin/Idarubicin + Cytarabine) | Active comparator | Induction Cycle 1:
* Cytarabine: 100 mg/m²/day, days 1-7
* Daunorubicin: 60 mg/m²/day, days 1-3 or
* Idarubicin: 12 mg/m²/day, days 1-3
• Induction Cycle 2 (if CR/CRi/CRh not achieved after Cycle 1):
* Cyclophosphamide: 350 mg/m²/day, days 2 and 5o Cytarabine: 100 mg/m²/day, days 1-7
* Daunorubicin: 45 mg/m²/day, days 1-2 or
* Idarubicin: 8 mg/m²/day, days 1-2
Consolidation Therapy
• Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles
Maintenance Therapy
* Low/Intermediate-Risk Patients:
1. DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2
2. VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral
* High-Risk Patients:
VA Regimen, 6 cycles
Allogeneic Transplantation:
Recommended for high-risk patients and those with persistent MRD positivity. Receives: Drug: Daunorubicin/Idarubicin; Drug: Cytarabine; Drug: Azacitidine; Drug: Venetoclax |
| VA Regimen | Experimental | Induction Cycles
* Azacitidine: 75 mg/m²/day, days 1-7
* Venetoclax:
Day 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg/day If bone marrow blasts >5% on day 21, extend to day 28 with 400 mg/day
• Efficacy will be assessed after 2 cycles. If CR/CRi/CRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered.
Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles
Maintenance Therapy
* Low/Intermediate-Risk Patients:
1: DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2
2.VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral
* High-Risk Patients:
* VA Regimen, 6 cycles
Allogeneic Transplantation:
Recommended for high-risk patients and those with persistent MRD positivity. Receives: Drug: Cytarabine; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: up to 1 years after completion of enrollment
Secondary outcomes (5)
Composite Complete Remission Rate (CR/CRh/CRi)
Proportion of patients achieving CR, CRh, or CRi after induction.
Measured: Six weeks after induction therapy
MRD Negativity Rate
Proportion of patients achieving MRD negativity after induction and overall treatment.
Measured: up to 1 years after completion of enrollment
Relapse-Free Survival (RFS)
Time from achieving CR/CRh/CRi to relapse or death.
Measured: up to 1 years after completion of enrollment
Event-Free Survival (EFS)
Time from randomization to treatment failure, relapse, or death.
Measured: up to 1 years after completion of enrollment
30-Day and 60-Day Mortality Rates
Proportion of patients who die within 30 and 60 days of starting treatment.
Measured: within 30 and 60 days of starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start31 Aug 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wei, MD, Principal investigator, Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132684
- Sponsor's protocol ID
- IIT2025095
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT07132684
- Acronym / sponsor ID
- IIT2025095
- Conditions
- AML, Adult
- Keywords
- acute myeloid leukemia, Older fit patients, venetoclax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 20 Aug 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.
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D/IA (Daunorubicin/Idarubicin + Cytarabine) | Active comparator | Drug: Daunorubicin/Idarubicin, Drug: Cytarabine, Drug: Azacitidine, Drug: VenetoclaxInduction Cycle 1: * Cytarabine: 100 mg/m²/day, days 1-7 * Daunorubicin: 60 mg/m²/day, days 1-3 or * Idarubicin: 12 mg/m²/day, days 1-3 • Induction Cycle 2 (if CR/CRi/CRh not achieved after Cycle 1): * Cyclophosphamide: 350 mg/m²/day, days 2 and 5o Cytarabine: 100 mg/m²/day, days 1-7 * Daunorubicin: 45 mg/m²/day, days 1-2 or * Idarubicin: 8 mg/m²/day, days 1-2 Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy * Low/Intermediate-Risk Patients: 1. DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2 2. VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral * High-Risk Patients: VA Regimen, 6 cycles Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity. |
| VA Regimen | Experimental | Drug: Cytarabine, Drug: Azacitidine, Drug: VenetoclaxInduction Cycles * Azacitidine: 75 mg/m²/day, days 1-7 * Venetoclax: Day 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg/day If bone marrow blasts >5% on day 21, extend to day 28 with 400 mg/day • Efficacy will be assessed after 2 cycles. If CR/CRi/CRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered. Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Maintenance Therapy * Low/Intermediate-Risk Patients: 1: DA/IA "2+5" Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2 2.VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral * High-Risk Patients: * VA Regimen, 6 cycles Allogeneic Transplantation: Recommended for high-risk patients and those with persistent MRD positivity. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of AML according to WHO (2022) or ICC criteria.
- Age ≥55 and ≤75 years.
- ECOG performance status score of 0-2.
- Adequate organ function:
Key exclusion criteria (8 listed)
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
- Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
- Concurrent other malignancies 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 |
|---|---|---|
| Daunorubicin/IdarubicinDaunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy. | Drug | D/IA (Daunorubicin/Idarubicin + Cytarabine) |
| CytarabineCytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy. | Drug | D/IA (Daunorubicin/Idarubicin + Cytarabine), VA Regimen |
| AzacitidineAzacitidine is used in VA regimen | Drug | D/IA (Daunorubicin/Idarubicin + Cytarabine), VA Regimen |
| VenetoclaxVenetoclax is used in VA regimen | Drug | D/IA (Daunorubicin/Idarubicin + Cytarabine), VA Regimen |
Primary outcome
Overall Survival (OS)
Time frame: up to 1 years after completion of enrollment
Time from randomization to death from any cause.
5 secondary outcomes
Composite Complete Remission Rate (CR/CRh/CRi)
Time frame: Six weeks after induction therapy
MRD Negativity Rate
Time frame: up to 1 years after completion of enrollment
Relapse-Free Survival (RFS)
Time frame: up to 1 years after completion of enrollment
Event-Free Survival (EFS)
Time frame: up to 1 years after completion of enrollment
30-Day and 60-Day Mortality Rates
Time frame: within 30 and 60 days of starting treatment.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hui Wei, MD principal investigator
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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 Daunorubicin/Idarubicin, Cytarabine and Azacitidine in people with AML, Adult, 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 9 inclusion and 8 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 26 Oct 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.
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 Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: up to 1 years after completion of enrollment). 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 26 Oct 2026.