A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia

NCT ID: NCT06116318

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-11-01

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MRD negative

c-Kit mutation tested negative

No interventions assigned to this group

MRD L1

MRD detection at low level-1：\<0.001%

No interventions assigned to this group

MRD L2

MRD detection at low level-2：0.001%≤c-Kit MRD\<0.01%

No interventions assigned to this group

MRD L3

detection at low level-3：0.01%≤c-Kit MRD\<0.1%

No interventions assigned to this group

MRD positive

MRD positive：c-Kit MRD≥0.1%

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.

Exclusion Criteria

Patients with other factors which were considered unsuitable to participate in the study by the investigators

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Wei, Doctor

Role: CONTACT

weihui@ihcams.ac.cn

13132507161

Facility Contacts

Hui Wei, MD

Role: primary

Other Identifiers

QT2023009

Identifier Type: -

Identifier Source: org_study_id