Summary of key inclusion criteria and TKI retreatment triggers used in clinical trials
Study . | TKI . | Number of patients reported . | Required depth of MR . | Minimum duration of MR (years) . | Trigger to resume TKI . |
---|---|---|---|---|---|
STIM20 | Imatinib (±prior IFN) | 100 | UMRD (MR5.0) | 2 | Loss of UMRD* |
TWISTER21 | Imatinib (±prior IFN) | 40 | UMRD (MR4.5) | 2 | Loss of UMRD |
A-STIM22 | Imatinib (±prior IFN) | 80 | UMRD† | 2 | Loss of MMR |
EuroSKI24 | Imatinib/nilotinib/dasatinib | 200 | MR4.0 | 1 | Loss of MMR |
Stop 2GTKI28 | Nilotinib/dasatinib first and second line | 52 | UMRD (MR4.5) | 2 | Loss of MMR |
KIDS25 | Imatinib (±prior IFN) | 90 | UMRD (MR4.5) | 2 | Loss of MMR |
HOVON32 | Imatinib | 18 | UMRD (MR4.5) | 2 | Loss of UMRD |
DADI27 | Second-line dasatinib | 63 | MR4.0 | 1 | Loss of MR4.0 |
STIM226 | Imatinib | 124 | UMRD (MR4.5) | 2 | Loss of UMRD |
Study . | TKI . | Number of patients reported . | Required depth of MR . | Minimum duration of MR (years) . | Trigger to resume TKI . |
---|---|---|---|---|---|
STIM20 | Imatinib (±prior IFN) | 100 | UMRD (MR5.0) | 2 | Loss of UMRD* |
TWISTER21 | Imatinib (±prior IFN) | 40 | UMRD (MR4.5) | 2 | Loss of UMRD |
A-STIM22 | Imatinib (±prior IFN) | 80 | UMRD† | 2 | Loss of MMR |
EuroSKI24 | Imatinib/nilotinib/dasatinib | 200 | MR4.0 | 1 | Loss of MMR |
Stop 2GTKI28 | Nilotinib/dasatinib first and second line | 52 | UMRD (MR4.5) | 2 | Loss of MMR |
KIDS25 | Imatinib (±prior IFN) | 90 | UMRD (MR4.5) | 2 | Loss of MMR |
HOVON32 | Imatinib | 18 | UMRD (MR4.5) | 2 | Loss of UMRD |
DADI27 | Second-line dasatinib | 63 | MR4.0 | 1 | Loss of MR4.0 |
STIM226 | Imatinib | 124 | UMRD (MR4.5) | 2 | Loss of UMRD |
DADI, Dasatinib Discontinuation study; HOVON, Stichting Hemato-Oncologie voor Volwassenen Nederland.
A-STIM allowed occasional low level positive RQ-PCR results during the 2 years of UMRD.
Loss of UMRD in STIM and STIM2 was defined as ≥2 consecutive samples with detectable BCR-ABL and a 1-log increase; in TWISTER and the HOVON study, any 2 consecutive samples at any level were considered loss of UMRD.