Risk-directed TherapyNCT03620955
Risk-stratified Therapy Based on Molecular Cytogenetic Aberration and Treatment Response in AML
An observational study of Risk-directed Therapy and Cytogenetic Abnormality, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Risk-directed Therapy, Cytogenetic Abnormality, Molecular Abnormality
- What is being tested?
- Justified risk stratification based on MRD after three course chemo therapy
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2018to Dec 2021
- Phase
- Observational
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old.
Who may be able to join
- All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old
Who cannot join
- Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
1 site in 1 country.
Qifa Liu contact
China1 site, 1 recruiting
- Recruiting
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Qifa Liu
Guopan Yu, yugpp@163.com
About this study
Official title: Risk-stratified Therapy Based on Molecular and Cytogenetic Aberration and Treatment Response in Acute Myeloid Leukemia
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.
Read the detailed description
Risk-stratified therapy based on cytogenetic and molecular characteristic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown the important role of early treatment response presenting as minimal residual disease (MRD) in prognostic prediction. In this study, we perform risk stratification based on not only cytogenetic and molecular characteristic, but also MRD levels after three courses of chemo therapy. We stratified all patients into different risk groups according to the NCCN guild based on cytogenetic and molecular. Then we treat all patients with anthracycline combined with cytarabine regimens for two courses (First cycle: IDA 12mg/m2 or DNR 60mg/m2, d1-3, Ara-C 100mg/m2 d1-7; Second cycle: IDA 10mg/m2 or DNR 45mg/m2, d1-3, Ara-C 2g/m2 q12h, d1-3) . The patients without obtaining complete remission (CR) will go on one cycle of salvage therapy and then be bridged to allogeneic (allo-) hemopoietic stem cell transplantation (HSCT). Those acquiring CR will be given one course of high dose cytarabine (HDAC) as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.The patients with MRD negative in low risk group are given HDAC (Ara-C 2g/m2 q12h, d1-3) for 3 cycles. If MRD is continuously negative in this cohort, chemotherapy will be stopped and MRD will be continuously monitored to the third year after the diagnosis. The patients with MRD negative in medium risk group are suggested to receive allo-HSCT if a HLA-matched sibling donor is available, or autologous (auto-) HSCT after receiving HDAC regimen for one more cycle if no HLA-matched sibling donors are available. The patients with MRD positive in low or medium-risk group or the cases in high-risk group are going to be bridged into allo-HSCT if a donor is available including haploid donors. The aim of this study is to evaluate whether the new stratification system benefits AML patients with better OS and DFS.
- Being tested
- Justified risk stratification based on MRD after three course chemo therapy
- Medical subject headings
- Chromosome Aberrations, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Justified risk stratification based on MRD after three course chemo therapyOther
All patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.
| Study group | Role | What they receive |
|---|---|---|
| Risk stratification | Risk stratification based on cytogenetic and molecular and MRD level after three courses of chemo therapy. Receives: Other: Justified risk stratification based on MRD after three course chemo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
Measured: 2 year
Secondary outcomes (2)
overall survival (OS)
Measured: 2 year
disease-free survival (DFS)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start10 Aug 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk-directed TherapyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Wuhan General Hospital of Guangzhou Military Command, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital, Shenzhen Second People's Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Gannan Medical University, Peking University People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Chenzhou NO. 1 people's Hospital
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620955
- Sponsor's protocol ID
- Risk stratification in AML
- Status last verified
- Oct 2019
- First submitted
- 5 Aug 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu S, Liu H, Zhao W, Yu G, Shi P, Nie D, Sun Z, Liu Q, Shao R, Feng Z, Liang X, Zhang X, Du X, Xu X, Wang S, Zhang Q, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu Q, Liang Q, Liu C, Wu M, Weng G, Lin R, Jin H, Sun J, Wang Y, Xuan L, Zhang Y, Liu Q. Autologous transplant versus matched sibling donor transplant in intermediate-risk AML in CR1 with no detectable MRD: a biological assignment comparative study. Exp Hematol Oncol. 2026 Jul 6;15(1):67. doi: 10.1186/s40164-026-00807-y.
PubMed 42410464Zhang Y, Feng Z, Du J, Liu H, Yu S, Liang X, Zhao W, Zhang Q, Zhang X, Nie D, Sun Z, Du X, Xu X, Yu G, Shi P, Liu Q, Shao R, Qu H, Xiong W, Wang S, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu C, Wu M, Lin R, Jin H, Sun J, Liu Q, Xuan L. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia. 2025 Aug;39(8):1857-1864. doi: 10.1038/s41375-025-02655-x. Epub 2025 May 28.
PubMed 40437173
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-stratified Therapy Based on Molecular and Cytogenetic Aberration and Treatment Response in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03620955
- Acronym / sponsor ID
- Risk stratification in AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Wuhan General Hospital of Guangzhou Military Command, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital, Shenzhen Second People's Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Gannan Medical University, Peking University People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Chenzhou NO. 1 people's Hospital
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Aug 2018 (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.
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.
Detailed description
Risk-stratified therapy based on cytogenetic and molecular characteristic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown the important role of early treatment response presenting as minimal residual disease (MRD) in prognostic prediction. In this study, we perform risk stratification based on not only cytogenetic and molecular characteristic, but also MRD levels after three courses of chemo therapy. We stratified all patients into different risk groups according to the NCCN guild based on cytogenetic and molecular. Then we treat all patients with anthracycline combined with cytarabine regimens for two courses (First cycle: IDA 12mg/m2 or DNR 60mg/m2, d1-3, Ara-C 100mg/m2 d1-7; Second cycle: IDA 10mg/m2 or DNR 45mg/m2, d1-3, Ara-C 2g/m2 q12h, d1-3) . The patients without obtaining complete remission (CR) will go on one cycle of salvage therapy and then be bridged to allogeneic (allo-) hemopoietic stem cell transplantation (HSCT). Those acquiring CR will be given one course of high dose cytarabine (HDAC) as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.The patients with MRD negative in low risk group are given HDAC (Ara-C 2g/m2 q12h, d1-3) for 3 cycles. If MRD is continuously negative in this cohort, chemotherapy will be stopped and MRD will be continuously monitored to the third year after the diagnosis. The patients with MRD negative in medium risk group are suggested to receive allo-HSCT if a HLA-matched sibling donor is available, or autologous (auto-) HSCT after receiving HDAC regimen for one more cycle if no HLA-matched sibling donors are available. The patients with MRD positive in low or medium-risk group or the cases in high-risk group are going to be bridged into allo-HSCT if a donor is available including haploid donors. The aim of this study is to evaluate whether the new stratification system benefits AML patients with better OS and DFS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk stratification | – | Other: Justified risk stratification based on MRD after three course chemo therapyRisk stratification based on cytogenetic and molecular and MRD level after three courses of chemo therapy. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old.
Key inclusion criteria (1 listed)
- All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old
Key exclusion criteria (1 listed)
- Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)
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 |
|---|---|---|
| Justified risk stratification based on MRD after three course chemo therapyAll patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification. | Other | Risk stratification |
Primary outcome
relapse rate
Time frame: 2 year
2 secondary outcomes
overall survival (OS)
Time frame: 2 year
disease-free survival (DFS)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 42410464Yu S, Liu H, Zhao W, Yu G, Shi P, Nie D, Sun Z, Liu Q, Shao R, Feng Z, Liang X, Zhang X, Du X, Xu X, Wang S, Zhang Q, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu Q, Liang Q, Liu C, Wu M, Weng G, Lin R, Jin H, Sun J, Wang Y, Xuan L, Zhang Y, Liu Q. Autologous transplant versus matched sibling donor transplant in intermediate-risk AML in CR1 with no detectable MRD: a biological assignment comparative study. Exp Hematol Oncol. 2026 Jul 6;15(1):67. doi: 10.1186/s40164-026-00807-y.
- Derived from this study: PubMed 40437173Zhang Y, Feng Z, Du J, Liu H, Yu S, Liang X, Zhao W, Zhang Q, Zhang X, Nie D, Sun Z, Du X, Xu X, Yu G, Shi P, Liu Q, Shao R, Qu H, Xiong W, Wang S, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu C, Wu M, Lin R, Jin H, Sun J, Liu Q, Xuan L. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia. 2025 Aug;39(8):1857-1864. doi: 10.1038/s41375-025-02655-x. Epub 2025 May 28.
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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.
Qifa Liu contact
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk-directed Therapy and Cytogenetic Abnormality, run by Nanfang Hospital, Southern Medical University 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 1 inclusion and 1 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 4 Nov 2019. 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 Qifa Liu (liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (time frame: 2 year). 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 NCT03620955, which also lists 2 linked publications.
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 4 Nov 2019.