Table 1

ELN operational definition of failure and suboptimal response for previously untreated, early chronic phase CML patients treated with 400 mg IM daily

TimeFailureSuboptimal responseWarnings
Diagnosis NA NA High risk 
   del 9q+ 
   Additional chromosome abnormalities (ACA) in Ph+ cells 
3 months No hematologic response (HR) (stable disease or disease progression) Less than complete hematologic response (CHR)  
6 months Less than CHR Less than partial cytogenetic response  
 No cytogenetic response (Ph+ > 95%) (Ph+ > 35%)  
12 months Less than partial cytogenetic response (Ph+ > 35%) Less than complete cytogenetic response Less than major molecular response (MMR) 
18 months Less than complete cytogenetic response Less than MMR  
At any time Loss of CHR* ACA in Ph+ cells§ Any rise in transcript level 
 Loss of complete cytogenetic response Loss of MMR§ ACA in Ph cells 
 Mutation Mutation  
TimeFailureSuboptimal responseWarnings
Diagnosis NA NA High risk 
   del 9q+ 
   Additional chromosome abnormalities (ACA) in Ph+ cells 
3 months No hematologic response (HR) (stable disease or disease progression) Less than complete hematologic response (CHR)  
6 months Less than CHR Less than partial cytogenetic response  
 No cytogenetic response (Ph+ > 95%) (Ph+ > 35%)  
12 months Less than partial cytogenetic response (Ph+ > 35%) Less than complete cytogenetic response Less than major molecular response (MMR) 
18 months Less than complete cytogenetic response Less than MMR  
At any time Loss of CHR* ACA in Ph+ cells§ Any rise in transcript level 
 Loss of complete cytogenetic response Loss of MMR§ ACA in Ph cells 
 Mutation Mutation  

Failure implies that the patient should be moved to other treatments whenever available. Suboptimal response implies that the patient may still derive substantial benefit from continuing IM treatment but that the long-term outcome is probably not optimal, so that the patient will become eligible for other treatment. Warnings imply that the patient should be monitored very carefully and may become eligible for other treatments.

NA indicates not applicable.

*

To be confirmed on two occasions unless associated with progression to AP/BC.

To be confirmed on two occasions, unless associated with CHR loss or progression to AP/BC.

High level of insensitivity to imatinib.

§

To be confirmed on two occasions, unless associated with loss of CHR or loss of complete cytogenetic response.

Low level of insensitivity to imatinib.

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