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A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

NCT06368414 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-04-02

No results posted yet for this study

Summary

To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DRUG

Asciminib

that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation

Sponsors & Collaborators

  • Korean Society of Hematology

    lead NETWORK

Principal Investigators

  • Hawk Kim · Korean Society of Hematology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368414 on ClinicalTrials.gov