AMLPhase 3NCT03021330
Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
A Phase 3 study testing Daunomycin and Cytarabine (DA Regimen) and Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- AML
- What is being tested?
- Daunomycin and Cytarabine (DA Regimen) and Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2017to 15 Oct 2027
- 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 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of 14 to 55 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- ECOG score ≤ 2;
- Patients with eligible laboratory examination including liver,renal and heart function.
- Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
Who cannot join
- Patients who had received induction therapy.
- Secondary leukemia.
- Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
- Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- With BCR-ABL fusion gene;
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- Pregnant or lactating women;
- AML with ineligible renal or liver function;
- AML with active cardiovascular disease;
- Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
- AIDS;
- Patients had central nervous system involvement when they were diagnosed as AML.
- Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
- Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
- Patients with other factors which were considered unsuitable to participate in the study by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
About this study
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Read the detailed description
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
- Conditions
- AML
- Being tested
- Daunomycin and Cytarabine (DA Regimen), Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daunomycin and Cytarabine (DA Regimen)Drug
Also called Daunomycin and Cytarabine
Cytarabine at a dose of 100mg/㎡/d on day 1-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)Drug
Also called Daunomycin and Cytarabine
Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
| Study group | Role | What they receive |
|---|---|---|
| DA Regimen | Active comparator | Patients receive standard DA induction regimen including daunomycin and cytarabine. Receives: Drug: Daunomycin and Cytarabine (DA Regimen) |
| Intermediate Dose of DA Regimen | Experimental | Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine. Receives: Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Within 5 years after randomization
Secondary outcomes (5)
Complete Remission Rate
Measured: Within 2 months after randomization
Event-Free Survival Rate
Measured: Within 5 years after randomization
Relapse-Free Survival Rate (RFS)
Measured: Within 5 years after randomization
Cumulative incidence of relapse
Measured: Within 5 years after randomization
Early Mortality
Measured: within 45 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion15 May 2026 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021330
- Sponsor's protocol ID
- IIT2016007（Cytarabine）
- Status last verified
- May 2025
- First submitted
- 12 Jan 2017
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
- ClinicalTrials.gov ID
- NCT03021330
- Acronym / sponsor ID
- IIT2016007（Cytarabine）
- Conditions
- AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- 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.
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Detailed description
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA Regimen | Active comparator | Drug: Daunomycin and Cytarabine (DA Regimen)Patients receive standard DA induction regimen including daunomycin and cytarabine. |
| Intermediate Dose of DA Regimen | Experimental | Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age of 14 to 55 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- ECOG score ≤ 2;
- Patients with eligible laboratory examination including liver,renal and heart function.
- Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
Key exclusion criteria (15 listed)
- Patients who had received induction therapy.
- Secondary leukemia.
- Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
- Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
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 |
|---|---|---|
| Daunomycin and Cytarabine (DA Regimen)Also: Daunomycin and CytarabineCytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3. | Drug | DA Regimen |
| Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)Also: Daunomycin and CytarabineCytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3. | Drug | Intermediate Dose of DA Regimen |
Primary outcome
Overall Survival Rate (OS)
Time frame: Within 5 years after randomization
OS is defined as the time from the date of randomization until the date of death from any cause.
5 secondary outcomes
Complete Remission Rate
Time frame: Within 2 months after randomization
Event-Free Survival Rate
Time frame: Within 5 years after randomization
Relapse-Free Survival Rate (RFS)
Time frame: Within 5 years after randomization
Cumulative incidence of relapse
Time frame: Within 5 years after randomization
Early Mortality
Time frame: within 45 days after randomization
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 30 May 2025.
- 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. This study is not recruiting at the moment.
Jianxiang Wang, Dr 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 Phase 3 study testing Daunomycin and Cytarabine (DA Regimen) and Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) in people with AML, 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 5 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: 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 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?
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?
Overall Survival Rate (OS) (time frame: Within 5 years after randomization). 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 30 May 2025.