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Clinical Trial Summary

To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.


Clinical Trial Description

Primary Objectives: • To assess the rate of major molecular response (MMR) by 12-months. Secondary Objectives: - To assess the rate of complete cytogenetic response (CCyR, or PCR ≤ 1% IS) by 12 months - To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6-, 12-,18-, 24-, and 36 months of therapy. - To estimate the rate of TFR - To estimate the time to progression, progression-free survival, and overall survival. - To assess the toxicity of this dosing schedule by evaluating the adverse events that occur while the participant is on asciminib therapy - To estimate the proportion of participants with sustained MR4.5 of 3 years and more. - To estimate the cumulative overall rate of MR4.5. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06236724
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Elias Jabbour, MD
Phone (713) 792-4764
Email ejabbour@mdanderson.org
Status Recruiting
Phase Phase 2
Start date January 31, 2024
Completion date July 1, 2035

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