AMLNCT07004816
The Mutation Profile and Prognosis in AML With IDH1/2 Mutation
An observational study of AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- AML
- What is being tested?
- Uncover mutation profiles
- How many people
- 1,015 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2017to 24 Mar 2020
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
Who may be able to join
- Age of less than 60 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- 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 with other blood diseases(for example, haemophiliacs) are excluded.
- With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- Had other malignant tumor in need of treatment;
- 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
Official title: The Mutation Profile and Prognosis in Acute Myeloid Leukemia With IDH1/2 Mutation
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
Read the detailed description
In this program, first, investigators want to uncover mutation profiles in the 500 AML patients including AML1-ETO CBFb-MYH11, MLL translocation, NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11 genetic alteration in addition to IDH1/2 mutation. These patients received regimen, which is consistent with NCCN and ELN guidelines. NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11, and IDH1/2 genetic alteration will be detected by targeted next generation sequencing. AML1-ETO and CBFb-MYH11 will be detected by RT-PCR. MLL translocation will be detected by FISH(fluorescence in situ hybridization).Next, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China. Then investigators will investigate mutation profile in IDH1/2 mutation AML patients. Finally, investigators will elucidate the prognostic effect of IDH1/2 mutation in AML. At last, investigators will instigate how mutation profile affects the prognosis in IDH1/2 mutation AML patients.
- Conditions
- AML
- Being tested
- Uncover mutation profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncover mutation profilesOther
Uncover mutation profiles
| Study group | Role | What they receive |
|---|---|---|
| AML patients | Uncover mutation profiles of newly-diagnosed AML patients Receives: Other: Uncover mutation profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Incidence is defined as the incidence of patients who carries IDH1/2 mutations
Measured: Before treatment
Secondary outcomes (2)
Relapse-Free Survival(RFS)
RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for subjects who achieve CR.
Measured: Up to 3 years
Overall Survival(OS)
OS is defined as the time from the date of randomization until the date of death from any cause
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start21 Dec 2017
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Adapted the plan
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004816
- Sponsor's protocol ID
- IIT2017004
- Status last verified
- May 2024
- First submitted
- 26 May 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mutation Profile and Prognosis in Acute Myeloid Leukemia With IDH1/2 Mutation
- ClinicalTrials.gov ID
- NCT07004816
- Acronym / sponsor ID
- IIT2017004
- Conditions
- AML
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Adapted the plan
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 4 Jun 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.
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
Detailed description
In this program, first, investigators want to uncover mutation profiles in the 500 AML patients including AML1-ETO CBFb-MYH11, MLL translocation, NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11 genetic alteration in addition to IDH1/2 mutation. These patients received regimen, which is consistent with NCCN and ELN guidelines. NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11, and IDH1/2 genetic alteration will be detected by targeted next generation sequencing. AML1-ETO and CBFb-MYH11 will be detected by RT-PCR. MLL translocation will be detected by FISH(fluorescence in situ hybridization).Next, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China. Then investigators will investigate mutation profile in IDH1/2 mutation AML patients. Finally, investigators will elucidate the prognostic effect of IDH1/2 mutation in AML. At last, investigators will instigate how mutation profile affects the prognosis in IDH1/2 mutation AML patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients | – | Other: Uncover mutation profilesUncover mutation profiles of newly-diagnosed AML patients |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
Key inclusion criteria (3 listed)
- Age of less than 60 years old;
- Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- 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 (5 listed)
- Patients with other blood diseases(for example, haemophiliacs) are excluded.
- With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
- Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- Had other malignant tumor in need of treatment;
- Patients with other factors which were considered unsuitable to participate in the study by the investigators.
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 |
|---|---|---|
| Uncover mutation profilesUncover mutation profiles | Other | AML patients |
Primary outcome
Incidence
Time frame: Before treatment
Incidence is defined as the incidence of patients who carries IDH1/2 mutations
2 secondary outcomes
Relapse-Free Survival(RFS)
Time frame: Up to 3 years
Overall Survival(OS)
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Adapted the plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 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: stopped early, as of the sponsor's last update on 18 Nov 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.
Are results available for this study?
The study was stopped early (reason given: Adapted the plan). Results are not available in the source record.
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?
Incidence (time frame: Before treatment). 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 18 Nov 2025.