C-KIT MutationNCT06116318
A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia
An observational study of C-KIT Mutation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- C-KIT Mutation
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute myeloid leukemia confirmed by bone marrow cell morphology, immunology, and genetics. And c-Kit D816 mutation was positive.
Who may be able to join
- Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.
Who cannot join
- 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.
About this study
Official title: Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study
C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.
- Conditions
- C-KIT Mutation
- Keywords
- Acute myeloid leukemia, c-Kit mutation, MRD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MRD negative | c-Kit mutation tested negative | |
| MRD L1 | MRD detection at low level-1：<0.001% | |
| MRD L2 | MRD detection at low level-2：0.001%≤c-Kit MRD<0.01% | |
| MRD L3 | detection at low level-3：0.01%≤c-Kit MRD<0.1% | |
| MRD positive | MRD positive：c-Kit MRD≥0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIR
cumulative incidence of recurrence
Measured: Within 5 years after treatment
Secondary outcomes (2)
OS
Overall Survival Rate
Measured: Within 5 years after treatment
RFS
Relapse-free survival
Measured: Within 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Why it stopped: The test for c-kit was not set up and replaced by NGS MRD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-KIT MutationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116318
- Sponsor's protocol ID
- QT2023009
- Status last verified
- May 2026
- First submitted
- 24 Oct 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06116318
- Acronym / sponsor ID
- QT2023009
- Conditions
- C-KIT Mutation
- Keywords
- Acute myeloid leukemia, c-Kit mutation, MRD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The test for c-kit was not set up and replaced by NGS MRD
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Nov 2023 (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.
C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MRD negative | – | –c-Kit mutation tested negative |
| MRD L1 | – | –MRD detection at low level-1：<0.001% |
| MRD L2 | – | –MRD detection at low level-2：0.001%≤c-Kit MRD<0.01% |
| MRD L3 | – | –detection at low level-3：0.01%≤c-Kit MRD<0.1% |
| MRD positive | – | –MRD positive：c-Kit MRD≥0.1% |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute myeloid leukemia confirmed by bone marrow cell morphology, immunology, and genetics. And c-Kit D816 mutation was positive.
Key inclusion criteria (1 listed)
- Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.
Key exclusion criteria (1 listed)
- 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.
Primary outcome
CIR
Time frame: Within 5 years after treatment
cumulative incidence of recurrence
2 secondary outcomes
OS
Time frame: Within 5 years after treatment
RFS
Time frame: Within 5 years after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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 C-KIT Mutation, 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 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: withdrawn, as of the sponsor's last update on 13 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
CIR (time frame: Within 5 years after 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 13 May 2026.