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

NCT06116318 | Recruiting

• 1 other identifier: QT2023009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Acute myeloid leukemia; c-Kit mutation; MRD

Outcome Measures

Primary Outcomes (1)

• CIR

  cumulative incidence of recurrence

  Within 5 years after treatment

Secondary Outcomes (2)

• OS

  Within 5 years after treatment

• RFS

  Within 5 years after treatment

Study Arms (5)

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%

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myeloid leukemia confirmed by bone marrow cell morphology, immunology, and genetics. And c-Kit D816 mutation was positive.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Hui Wei, Doctor

CONTACT

13132507161; weihui@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CN (1)