TIDEL-II: frontline use of @entity2213 in CML with early switch to XXXX for failure to achieve time-dependent molecular targets.

@entity1 @entity2212 @entity2213 @entity10542
UNASSIGNED: TIDEL-II was designed to optimise outcomes for newly-diagnosed @entity2212 ( @entity2212 ) @entity1 . Two sequential cohorts enrolled a total of 210 @entity1 , all commencing @entity2213 600 mg/day, with a planned dose escalation to 800mg/day for @entity1 with @entity2213 plasma trough level <1000 ng/mL on day 22 (19%). @entity1 were then assessed with molecular treatment targets: BCR-ABL1  <=10%,  <=1% and  <=0.1% at 3, 6 and 12 months, respectively. Cohort I @entity1 who failed to achieve targets were escalated to @entity2213 800 mg/day (if on 600mg/day), then subsequently switched to @entity10542 400 mg BID for failing the same target 3 months later. Cohort II @entity1 who failed to achieve targets switched to @entity10542 directly, as did @entity1 with intolerance or loss of response in either cohort. At 2 years, 55% of study @entity1 remained on @entity2213 , and 30% were on @entity10542 . Only 12% were >10% BCR-ABL1 at 3 months. Confirmed MMR was achieved in 64% and 73% at 12 and 24 months, respectively. MR(4.5) at 24 months was 34%. Overall and transformation-free survival was 96% and 95% at 3 years, respectively. This trial supports the feasibility and efficacy of an @entity2213 -based approach with selective switching to @entity10542 . Trial Registration #ACTRN12607000325404.
