Author’s recommendation or personal guidance of stopping TKIS in good responder patients outside a clinical trial
| Key prerequisites |
| Declaration to an international or national registry |
| Very strict molecular monitoring with a certified laboratory* expressing the results on the IS with sensitivity strictly >4-log |
| No patient history of resistance to treatment |
| Patients |
| Patients with CP-CML treated with TKI for at least 5 y |
| Three points of BCR-ABL level per year mandatory with MR4 during 3 following years or MR4.5 during 2 following years (1 point in MR4 could be acceptable) |
| Molecular monitoring during TFR |
| Monthly for the first 12 mo, every 2 mo in year 2, and every 3 mo thereafter |
| Molecular relapse |
| Defined by loss of MMR or BCR-ABL level IS >0.1%, which trigger for re-initiation of TKI therapy |
| Re-challenge the treatment with the same TKI in the following month after loss of MMR |
| Key prerequisites |
| Declaration to an international or national registry |
| Very strict molecular monitoring with a certified laboratory* expressing the results on the IS with sensitivity strictly >4-log |
| No patient history of resistance to treatment |
| Patients |
| Patients with CP-CML treated with TKI for at least 5 y |
| Three points of BCR-ABL level per year mandatory with MR4 during 3 following years or MR4.5 during 2 following years (1 point in MR4 could be acceptable) |
| Molecular monitoring during TFR |
| Monthly for the first 12 mo, every 2 mo in year 2, and every 3 mo thereafter |
| Molecular relapse |
| Defined by loss of MMR or BCR-ABL level IS >0.1%, which trigger for re-initiation of TKI therapy |
| Re-challenge the treatment with the same TKI in the following month after loss of MMR |
In Europe, the laboratories have been certified by the European Leukemia Net (www.leukemia-net.org).