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

ConditionChronic Myeloid Leukemia, Chronic Phase

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age19+

SponsorKorean Society of Hematology

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

19 year or older

CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more

Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.

Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening

Disqualifiers

Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).

Patients who are receiving any other investigational agents.

Patients who currently have uncontrolled infections

Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.

Trial design

Design model

Single group

Treatments tested in this trial

Asciminib
Drug
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

Treatment groups

69 Participants

are divided into 1 treatment group

Group A: Asciminib armOther 1 intervention

Trial outcomes

Primary outcomes

MR3.0 or less by 1 year

To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib

Time frame

by 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korean Society of Hematology

Lead sponsor

Source ClinicalTrials.gov

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