A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
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
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
Treatments tested in this trial
- Asciminib
Treatment groups
69 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov