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. 2018 Nov 30;2018(1):168–176. doi: 10.1182/asheducation-2018.1.168

Table 3.

Summary of selected larger clinical trials of TFR relative to depth and duration of DMR

Clinical study Patient no. TKI at time of cessation Depth of DMR Duration of DMR TKI restart criteria TFR success (follow-up)
STIM140 100 Imatinib UMRD ≥2 yr Loss of MMR or ≥1-log increase in BCR-ABL1 38% (60 mo)
TWISTER41 40 Imatinib UMRD ≥2 yr Loss of MMR or rising BCR-ABL1 on 2 consecutive tests 47.1% (24 mo)
KID49 90 Imatinib UMRD ≥2 yr Loss of UMRD on 2 consecutive tests of MMR loss 58.5% (24 mo)
STOP 2G-TKI44 60 Dasatinib or nilotinib UMRD ≥2 yr Loss of MMR 53.57% (48 mo)
A-STIM42 80 Imatinib UMRD (occasional weakly positive samples also eligible) ≥2 yr Loss of MMR 61% (36 mo)
ENESTFreedom43 190 First-line nilotinib MR4.5 ≥1 yr Loss of MMR 51.6% (48 wk)
ENESTop47 126 Second-line nilotinib after imatinib MR4.5 ≥1 yr Loss of MMR or confirmed loss of MR4 53% (96 wk)
ISAV3 112 Imatinib MR4-MR4.5 ≥18 mo Loss of MMR 48.1% (21.6 mo)
DADI38 63 Second-line dasatinib MR4 or 0.0069% (IS) ≥1 yr Loss of DMR 44% (36 mo)
D-STOP50 54 Dasatinib MR4 ≥1 yr BCR-ABL1 > 0.0069% on 2 consecutive results 57% (24 mo)
EURO-SKI39 755 Imatinib > nilotinib/dasatinib MR4 ≥1 yr Loss of MMR 50% (24 mo)
Interim results
 STIM2 (interim)53 124 Imatinib UMRD ≥2 yr Loss of MMR or ≥1-log increase in BCR-ABL1 59% (12 mo)
 DASFREE (interim)54 84 Dasatinib (first or second line) MR4.5 ≥1 yr Loss of MMR 49% (12 mo)
 DESTINY55 117 Imatinib > dasatinib/nilotinib MR4 ≥1 yr Loss of MMR 77% (24 mo)

UMRD, undetectable molecular residual disease.