AML, AdultNCT07131059
MRD-positive AML Clinical Study
A study testing Ivosidenib, Gilteritinib and Venetoclax in people with AML, Adult, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- Ivosidenib, Gilteritinib and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2024to 30 Oct 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AML (non-M3) compliant with WHO (2016) standards;
- In morphological complete remission.
- Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.
- Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Who cannot join
- Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
- The diagnosis is APL
- Those who were not considered suitable for inclusion by the researchers.
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, Tianjin Municipality, 300020
Hui Wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study
This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.
Read the detailed description
Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11[4]. NGS can detect mutations such as FLT3.
For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.
This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.
- Conditions
- AML, Adult
- Being tested
- Ivosidenib, Gilteritinib, Venetoclax, Avapritinib, Daunorubicin
- Keywords
- Measurable Residual Disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvosidenibDrug
500mg d1-28
GilteritinibDrug
120mg d1-28
VenetoclaxDrug
400mg d1-21 ; 400mg d1-7; 400mg d1-28; 600mg d1-14
AvapritinibDrug
200mg d1-28.
DaunorubicinDrug
45mg/m2/d d1-2;
CytarabineDrug
100mg/m2/d d1-5
IdarubicinDrug
10mg/m2/d d1-2
MitoxantroneDrug
8mg/m2/d d1-2
HomoharringtonineDrug
2mg/m2/d d1-5
AzacitidineDrug
75mgd/m2 d1-7.
RuxolitinibDrug
20 mg twice daily, 28-day cycle
TrametinibDrug
12 mg twice daily, 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| With lDH1 gene mutation | Experimental | Ivosidenib 500mg/d: d1-28 ；Azacitidine 75mg/m2/d: d1-7；Venetoclax 600mg/d: d1-14 Receives: Drug: Ivosidenib; Drug: Venetoclax; Drug: Azacitidine |
| FLT3 gene mutation | Experimental | Gilteritinilb 120mg/d: d1-28； Venetocax 400mg/d: d1-7；Azacitidine 75mg/m2/d : d1-7 Receives: Drug: Gilteritinib; Drug: Venetoclax; Drug: Azacitidine |
| NPM1 mutation or IDH2 mutation | Experimental | Azacitidine 75mg/m2/d: d1-7；Venetoclax400mg/d: d1-21 or Cytarabine 20mg/m2/d : d1-10；Venetoclax 600mg/d: d1-21 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Azacitidine |
| c-kit mutation | Experimental | Avapritinib 200mg/ day, 28 days a course; Azacitidine 75mg/m2/d: d1-7 Receives: Drug: Avapritinib; Drug: Azacitidine |
| Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax | Experimental | Cytarabine 100mg/m2/d, d1-5； Daunorubicin 45mg/m2/d，d1-2； or Idarubicin 10mg/ m2/d，d1-2； or Mitoxantrone 8mg/ m2/d d1-2; Venetoclax 400mg d1-7 Receives: Drug: Venetoclax; Drug: Daunorubicin; Drug: Cytarabine; Drug: Idarubicin; Drug: Mitoxantrone |
| Cytarabine+Homoharringtonine+Venetoclax | Experimental | Cytarabine 100mg/ m2/d, d1-5; Homoharringtonine 2mg/ m2 d1-5; Venetoclax 400mg d1-7 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Homoharringtonine |
| Venetoclax+Azacitidine/Venetoclax+Cytarabine | Experimental | Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Azacitidine |
| JAK2 or CSF3R T618I mutation | Experimental | Azacitidine 75 mg/m² on days 1-7 Ruxolitinib 20 mg twice daily, 28-day cycle Receives: Drug: Azacitidine; Drug: Ruxolitinib |
| N-RAS and NF1 mutations | Experimental | Azacitidine 75 mg/m² on days 1-7 Tunlametinib 12 mg twice daily, 28-day cycle Receives: Drug: Azacitidine; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse-free survival rate
Measured: up to 6 months
Secondary outcomes (6)
Measurable Residual Disease
Measured: up to 6 months
Proportion of MRD turning negative
Measured: up to 6 months
Overall survival(OS ) rate
Measured: From the time the patients participated in the clinical trial until the patient died
Cumulative relapse rate
Measured: From the time the patients participated in the clinical trial until the patient relapsed
Adverse Events (AEs)
Measured: up to 2 years
The incidence of adverse events such as serious infections during treatment
Measured: up to 2 years
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 start11 May 2024
- Primary completion10 May 2028 (estimated)
- Study completion30 Oct 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.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 537 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huui Wei, doctor, Principal investigator, Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131059
- Sponsor's protocol ID
- IIT2024032
- Status last verified
- Aug 2026
- First submitted
- 12 May 2024
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study
- ClinicalTrials.gov ID
- NCT07131059
- Acronym / sponsor ID
- IIT2024032
- Conditions
- AML, Adult
- Keywords
- Measurable Residual Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 11 May 2024 (actual)
- Primary completion
- 10 May 2028 (estimated)
- Study completion
- 30 Oct 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 clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.
Detailed description
Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11[4]. NGS can detect mutations such as FLT3.
For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.
This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| With lDH1 gene mutation | Experimental | Drug: Ivosidenib, Drug: Venetoclax, Drug: AzacitidineIvosidenib 500mg/d: d1-28 ；Azacitidine 75mg/m2/d: d1-7；Venetoclax 600mg/d: d1-14 |
| FLT3 gene mutation | Experimental | Drug: Gilteritinib, Drug: Venetoclax, Drug: AzacitidineGilteritinilb 120mg/d: d1-28； Venetocax 400mg/d: d1-7；Azacitidine 75mg/m2/d : d1-7 |
| NPM1 mutation or IDH2 mutation | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: AzacitidineAzacitidine 75mg/m2/d: d1-7；Venetoclax400mg/d: d1-21 or Cytarabine 20mg/m2/d : d1-10；Venetoclax 600mg/d: d1-21 |
| c-kit mutation | Experimental | Drug: Avapritinib, Drug: AzacitidineAvapritinib 200mg/ day, 28 days a course; Azacitidine 75mg/m2/d: d1-7 |
| Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax | Experimental | Drug: Venetoclax, Drug: Daunorubicin, Drug: Cytarabine, Drug: Idarubicin, Drug: MitoxantroneCytarabine 100mg/m2/d, d1-5； Daunorubicin 45mg/m2/d，d1-2； or Idarubicin 10mg/ m2/d，d1-2； or Mitoxantrone 8mg/ m2/d d1-2; Venetoclax 400mg d1-7 |
| Cytarabine+Homoharringtonine+Venetoclax | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: HomoharringtonineCytarabine 100mg/ m2/d, d1-5; Homoharringtonine 2mg/ m2 d1-5; Venetoclax 400mg d1-7 |
| Venetoclax+Azacitidine/Venetoclax+Cytarabine | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: AzacitidineAzacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21 |
| JAK2 or CSF3R T618I mutation | Experimental | Drug: Azacitidine, Drug: RuxolitinibAzacitidine 75 mg/m² on days 1-7 Ruxolitinib 20 mg twice daily, 28-day cycle |
| N-RAS and NF1 mutations | Experimental | Drug: Azacitidine, Drug: TrametinibAzacitidine 75 mg/m² on days 1-7 Tunlametinib 12 mg twice daily, 28-day cycle |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- AML (non-M3) compliant with WHO (2016) standards;
- In morphological complete remission.
- Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.
- Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Key exclusion criteria (3 listed)
- Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
- The diagnosis is APL
- Those who were not considered suitable for inclusion by the researchers.
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 |
|---|---|---|
| Ivosidenib500mg d1-28 | Drug | With lDH1 gene mutation |
| Gilteritinib120mg d1-28 | Drug | FLT3 gene mutation |
| Venetoclax400mg d1-21 ; 400mg d1-7; 400mg d1-28; 600mg d1-14 | Drug | Cytarabine+Homoharringtonine+Venetoclax, Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax, FLT3 gene mutation, NPM1 mutation or IDH2 mutation, Venetoclax+Azacitidine/Venetoclax+Cytarabine, With lDH1 gene mutation |
| Avapritinib200mg d1-28. | Drug | c-kit mutation |
| Daunorubicin45mg/m2/d d1-2; | Drug | Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax |
| Cytarabine100mg/m2/d d1-5 | Drug | Cytarabine+Homoharringtonine+Venetoclax, Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax, NPM1 mutation or IDH2 mutation, Venetoclax+Azacitidine/Venetoclax+Cytarabine |
| Idarubicin10mg/m2/d d1-2 | Drug | Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax |
| Mitoxantrone8mg/m2/d d1-2 | Drug | Daunorubicin/Mitoxantrone/Idarubicin+Cytarabine +Venetoclax |
| Homoharringtonine2mg/m2/d d1-5 | Drug | Cytarabine+Homoharringtonine+Venetoclax |
| Azacitidine75mgd/m2 d1-7. | Drug | FLT3 gene mutation, JAK2 or CSF3R T618I mutation, N-RAS and NF1 mutations, NPM1 mutation or IDH2 mutation, Venetoclax+Azacitidine/Venetoclax+Cytarabine, With lDH1 gene mutation, c-kit mutation |
| Ruxolitinib20 mg twice daily, 28-day cycle | Drug | JAK2 or CSF3R T618I mutation |
| Trametinib12 mg twice daily, 28-day cycle | Drug | N-RAS and NF1 mutations |
Primary outcome
relapse-free survival rate
Time frame: up to 6 months
6 secondary outcomes
Measurable Residual Disease
Time frame: up to 6 months
Proportion of MRD turning negative
Time frame: up to 6 months
Overall survival(OS ) rate
Time frame: From the time the patients participated in the clinical trial until the patient died
Cumulative relapse rate
Time frame: From the time the patients participated in the clinical trial until the patient relapsed
Adverse Events (AEs)
Time frame: up to 2 years
The incidence of adverse events such as serious infections during treatment
Time frame: up to 2 years
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 10 Aug 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.
Huui Wei, doctor 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 study testing Ivosidenib, Gilteritinib and Venetoclax 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 4 inclusion and 3 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 10 Aug 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.
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, Doctor (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?
relapse-free survival rate (time frame: up to 6 months). 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 10 Aug 2026.