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

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.

Study Overview

• Status: Withdrawn
• Conditions: C-KIT Mutation

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CIR	cumulative incidence of recurrence	Within 5 years after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival Rate	Within 5 years after treatment
RFS	Relapse-free survival	Within 5 years after treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Acute myeloid leukemia; MRD; c-Kit mutation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: QT2023009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No