Table 2

Potential risk model, definitions, and suggested treatment algorithms in CLL

Risk groupDefinitionTreatment
Highest-risk F-refractory CLL
Early relapse (≤ 24 mo) after FCR (or FCR-like) treatment
TP53 deletion/mutation and indication for treatment 
Alternative induction with novel agent in clinical trial/alemtuzumab in general practice
Consolidation with allogeneic SCT
Maintenance (in clinical trial) 
High-risk Unmutated IGHV, 11q deletion, high β2-MG, no highest-risk traits FCR + investigational agent (in induction/maintenance) 
Low-risk None of the above, no prior treatment FCR, consider de-escalation, potentially MRD-based 
Risk groupDefinitionTreatment
Highest-risk F-refractory CLL
Early relapse (≤ 24 mo) after FCR (or FCR-like) treatment
TP53 deletion/mutation and indication for treatment 
Alternative induction with novel agent in clinical trial/alemtuzumab in general practice
Consolidation with allogeneic SCT
Maintenance (in clinical trial) 
High-risk Unmutated IGHV, 11q deletion, high β2-MG, no highest-risk traits FCR + investigational agent (in induction/maintenance) 
Low-risk None of the above, no prior treatment FCR, consider de-escalation, potentially MRD-based 

The risk model takes into account 3 groups of patients. The “highest-risk” group may be defined based on predicted failure to respond to FCR (TP53 loss/mutation; short or no response to FCR). There are a number of exciting substances in clinical development (eg, CAL-101; PCI 32765), which make inclusion into trials an attractive option. The high-risk category is expected to benefit from FCR (or similar), but relapse risk is high and there remains room for improvement in efficacy by investigational approaches. At relapse, these patients are still expected to respond to FCR or similar regimens. The low-risk group includes all other patients. In these, FCR (or similar) is of high efficacy, and the aim of future trials may be to achieve similar outcomes with less treatment toxicity.

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