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

C-KIT Mutation Clinical Trial

Official title:

Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116318
• Other study ID #: KIT-MRD-2023
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: November 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Hui Wei, Doctor
• Phone: 13132507161
• Email: weihui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C-KIT Mutation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIR	cumulative incidence of recurrence	Within 5 years after treatment
Secondary	OS	Overall Survival Rate	Within 5 years after treatment
Secondary	RFS	Relapse-free survival	Within 5 years after treatment