Acute Myeloid LeukemiaNCT02432872
Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years
A study testing Daunorubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Jianxiang Wang at 1 site in China.
Trial summary
The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Daunorubicin and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary AML（except APL patients）;
- ECOG PS:0-2
Who cannot join
- AML patient who has already received induction treatment, no matter what the outcome is;
- Treatment-related AML;
- Active cancer patients who's condition need to be treated;
- The one with serious infectious diseases（eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis）
- Active heart disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Treatment and Diagnosis Center of Leukemia
Tianjin, Tianjin Municipality, 300020
Jianxiang Wang, MD, +862223909120, wangjx@medmail.com.cn
Chunlin Zhou, MD, +8613820429085, zcl7317@sina.com
About this study
Official title: A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.
Read the detailed description
the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.
High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Daunorubicin, Cytarabine
- 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.
DaunorubicinDrug
Also called daunomycin
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
CytarabineDrug
Also called cytosine arabinoside
medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
| Study group | Role | What they receive |
|---|---|---|
| escalated daunorubicin | Experimental | Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. Receives: Drug: Daunorubicin; Drug: Cytarabine |
| standard daunorubicin | Active comparator | Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. Receives: Drug: Daunorubicin; Drug: Cytarabine |
| medium dosage cytarabine | Experimental | 1g/m2 q12h for 3 days as consolidation therapy. Receives: Drug: Cytarabine |
| standard dosage cytarabine | Active comparator | 100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy. Receives: Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Secondary outcomes (4)
complete remission rate
Measured: 2 months
relapse free survival
Measured: 3 years
complete remission rate in different risk group
Measured: 2 month
treatment-related mortality
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianxiang Wang
- Responsible party
- Sponsor-investigator, Jianxiang Wang, Chinese Academy of Medical Sciences
- Investigators
- Jianxiang Wang, MD, Principal investigator, ChineseAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432872
- Sponsor's protocol ID
- IHBDH-IIT2015002
- Status last verified
- May 2016
- First submitted
- 29 Apr 2015
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhou C, Li L, Li Y, Liu K, Liu Y, Lin D, Gong B, Zhang G, Gong X, Fang Q, Liu B, Qiu S, Wang Y, Wei H, Mi Y, Wang J. Daunorubicin-45 Vs. Daunorubicin-60 for Induction in Intermediate-Age Patients of AML: Results From a Randomized Trial. Cancer Sci. 2026 Jun;117(6):1690-1700. doi: 10.1111/cas.70383. Epub 2026 Apr 15.
PubMed 41986965
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
- ClinicalTrials.gov ID
- NCT02432872
- Acronym / sponsor ID
- IHBDH-IIT2015002
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jianxiang Wang
- Study start
- Apr 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 May 2015 (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.
The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.
Detailed description
the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.
High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| escalated daunorubicin | Experimental | Drug: Daunorubicin, Drug: CytarabineDaumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. |
| standard daunorubicin | Active comparator | Drug: Daunorubicin, Drug: CytarabineDaunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. |
| medium dosage cytarabine | Experimental | Drug: Cytarabine1g/m2 q12h for 3 days as consolidation therapy. |
| standard dosage cytarabine | Active comparator | Drug: Cytarabine100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary AML（except APL patients）;
- ECOG PS:0-2
Key exclusion criteria (5 listed)
- AML patient who has already received induction treatment, no matter what the outcome is;
- Treatment-related AML;
- Active cancer patients who's condition need to be treated;
- The one with serious infectious diseases（eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis）
- Active heart disease.
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 |
|---|---|---|
| DaunorubicinAlso: daunomycindefferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses | Drug | escalated daunorubicin, standard daunorubicin |
| CytarabineAlso: cytosine arabinosidemedium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy. | Drug | escalated daunorubicin, medium dosage cytarabine, standard daunorubicin, standard dosage cytarabine |
Primary outcome
overall survival
Time frame: 3 years
4 secondary outcomes
complete remission rate
Time frame: 2 months
relapse free survival
Time frame: 3 years
complete remission rate in different risk group
Time frame: 2 month
treatment-related mortality
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Derived from this study: PubMed 41986965Zhou C, Li L, Li Y, Liu K, Liu Y, Lin D, Gong B, Zhang G, Gong X, Fang Q, Liu B, Qiu S, Wang Y, Wei H, Mi Y, Wang J. Daunorubicin-45 Vs. Daunorubicin-60 for Induction in Intermediate-Age Patients of AML: Results From a Randomized Trial. Cancer Sci. 2026 Jun;117(6):1690-1700. doi: 10.1111/cas.70383. Epub 2026 Apr 15.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
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. This study is not recruiting at the moment.
Jianxiang Wang, MD principal investigator
ChineseAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daunorubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Jianxiang Wang 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlin - Zhou, MD (+8613820429085, zcl7317@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432872, which also lists 1 linked publication.
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 7 Oct 2016.