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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116318

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
C-KIT Mutation

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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%

Outcome Measures

Primary Outcome Measures

CIR [Within 5 years after treatment]
cumulative incidence of recurrence

Secondary Outcome Measures

OS [Within 5 years after treatment]
Overall Survival Rate
RFS [Within 5 years after treatment]
Relapse-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institute of Hematology & Blood Diseases Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wei Hui, MD, Director of Diagnosis and Treatment Center for Leukemia, Institute of Hematology & Blood Diseases Hospital, China

ClinicalTrials.gov Identifier:

NCT06116318

Other Study ID Numbers:

KIT-MRD-2023

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wei Hui, MD, Director of Diagnosis and Treatment Center for Leukemia, Institute of Hematology & Blood Diseases Hospital, China

Acute myeloid leukemia

c-Kit mutation

MRD

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Nov 3, 2023