Table 3.
| Study | Treatment prior to suspension of therapy | Study criteria for suspension of therapy | Trigger to reinitiate therapy |
|---|---|---|---|
| Nilo Post‐STIM (NCT01774630) | 2 years of nilotinib in patients who failed TFR in STIM1, STIM2, or EURO‐SKI | Stable CMR for 2 years | Confirmed loss of CMR |
| ENESTop (NCT01698905) | ≥3 years of TKI therapy prior to enrollment, including ≥4 weeks of frontline imatinib and ≥2 years of second‐line nilotinib, followed by a 1‐year nilotinib consolidation phase on study | ≥1 year MR4.5 | Loss of MMR or confirmed loss of MR4 |
| ENESTpath (NCT01743989) | ≥2 years of imatinib followed by 2 or 3 years of nilotinib | MR4 (≥1 year or ≥2 years) | Loss of MMR or confirmed loss of MR4 |
| ENESTgoal (NCT01744665) | ≥1 year of imatinib followed by ≥2 years of nilotinib | ≥2 years deep MR | Loss of MMR |
| ENESTfreedom (NCT01784068) | ≥2 years of frontline nilotinib prior to enrollment followed by a 1‐year nilotinib consolidation phase on study | ≥1 year MR4.5 | Loss of MMR |
| DASFREE (NCT01850004) | ≥2 years of dasatinib | ≥1 year MR4.5, confirmed at screening by a central laboratory | Loss of MMR |
| Dasatinib Stop (NCT01627132) | Dasatinib | CMR | Loss of CMR |
| Study for Cure D‐NEWS (NCT01887561) | Dasatinib | CMR | Loss of CMR |
| TIGER (NCT01657604) | Nilotinib or nilotinib + PEG‐IFNα | Stable MR4 | Loss of MMR |
| DESTINY (NCT01804985) | ≥3 years of imatinib, nilotinib, or dasatinib followed by 1 year at half‐standard dose | MMR or MR4 before dose de‐escalation | Loss of MMR |
| Imatinib or nilotinib with pegylated interferon‐α 2b in chronic myeloid leukemia (NCT00573378) | ≥2 years of nilotinib or imatinib followed by same TKI + PEG‐IFNα 2b | 24 months of combination therapy | Not specified |
CMR, complete molecular response; DESTINY, De‐Escalation and Stopping Treatment of Imatinib, Nilotinib, or Sprycel in Chronic Myeloid Leukemia; ENEST, Evaluating Nilotinib Efficacy and Safety; EURO‐SKI, European Stop Tyrosine Kinase Inhibitor; IS, International Scale; MMR, major molecular response (BCR‐ABL1 IS ≤0.1%); MR4, BCR‐ABL1 IS ≤0.01%; MR4.5, BCR‐ABL1 IS ≤0.0032%; PEG‐IFNα, pegylated interferon α; STIM, Stop Imatinib; TFR, treatment‐free remission; TIGER, Tasigna and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group; TKI, tyrosine kinase inhibitor.