Table 3.

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

^*In Europe, the laboratories have been certified by the European Leukemia Net (www.leukemia-net.org).