Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Medical College of Wisconsin
Summary
This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Description
All eligible patients will begin asciminib plus/minus TKI on cycle 1 day 1 of the consolidation phase. They will continue therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt. The primary endpoint of this study is the 12-month 'second' TFR rate after completion of 12 cycles of asciminib based therapy. Patients will remain in the TFR phase of the study for up to three years and will have central PCR testing during the first…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility for Consolidation Treatment Phase Inclusion Criteria: 1. Age ≥18 years old. 2. Willing and able to give informed consent. 3. Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 \^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility. 4. Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib, imatinib or ni…
Interventions
- DrugAsciminib 40 MG
40 mg by mouth (PO) when used with imatinib.
- DrugAsciminib 40 MG Twice Daily
40 mg twice daily when used with nilotinib.
- DrugAsciminib 80 MG daily
80 mg daily when used with dasatinib or taken alone.
- DrugImatinib
Maximum dose of 400 mg PO once daily.
- DrugNilotinib
Maximum dose of 300 mg twice daily.
- DrugDasatinib
Maximum dose of 100 mg PO once daily.
Locations (4)
- The Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Huntsman Cancer InstituteSalt Lake City, Utah
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin