Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (NCT05384587) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
United States34 participantsStarted 2022-11-11
Plain-language summary
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study
✓. CML-CP, no previous AP or BC
✓. ≥ 18 years of age
✓. ECOG performance status of 0, 1 or 2
✓. Adequate end organ function within 14 days before the first dose of asciminib treatment.
✓. Warning or failure (according to 2020 ELN Recommendations; Hochhaus et al) to 1L TKI therapy at the time of screening
✓. Treatment intolerance to 1L TKI,
✓. BCR::ABL1IS \> 0.1% at screening
Exclusion criteria
✕. Previous treatment
✕. With 2 or more ATP-binding site TKIs (for 2L patient cohort)
✕. More than 4 weeks with 1-ATP-binding site TKIs (for 1L patient cohort)
✕. Previous treatment with asciminib
✕. Known presence of the T315I mutation at any time prior to study entry
✕. Known second chronic phase of CML after previous progression to AP/BC
✕
What they're measuring
1
Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting