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

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: C-KIT Mutation

Study type: Observational

Funder types: Other

Identifiers

NCT06116318

QT2023009

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 5 patient groups

MRD negative

Description:

c-Kit mutation tested negative

MRD L1

Description:

MRD detection at low level-1：\<0.001%

MRD L2

Description:

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

MRD L3

Description:

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

MRD positive

Description:

MRD positive：c-Kit MRD≥0.1%