Table 3. Summary of selected larger... | American Society of Hematology

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)

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.