Table 4

Neurologic events and CRS leading to treatment interruption in long-term survivors

Patient No.*Blinatumomab dose (μg/m2/d)CycleAdverse event, CTCAE gradeBlinatumomab dose at restart of treatment (μg/m2/d)ProphylaxisResponse, RFS, OSAlive/In remission
15 Convulsion, grade 2 Clobazam CRh, Yes/No (relapse) 
RFS 17.5 mo, 
OS 38.6 mo 
20 30 Encephalopathy, grade 3 No CR, Yes/Yes 
RFS 34.1 mo, 
OS 36.9 mo 
10 CRS, grade 4 Prephase dexamethasone CRh, Yes/Yes 
RFS 22.4 mo, 
OS 30.0 mo 
Patient No.*Blinatumomab dose (μg/m2/d)CycleAdverse event, CTCAE gradeBlinatumomab dose at restart of treatment (μg/m2/d)ProphylaxisResponse, RFS, OSAlive/In remission
15 Convulsion, grade 2 Clobazam CRh, Yes/No (relapse) 
RFS 17.5 mo, 
OS 38.6 mo 
20 30 Encephalopathy, grade 3 No CR, Yes/Yes 
RFS 34.1 mo, 
OS 36.9 mo 
10 CRS, grade 4 Prephase dexamethasone CRh, Yes/Yes 
RFS 22.4 mo, 
OS 30.0 mo 

Long-term survivors were defined as patients with an OS ≥30 mo.

CTCAE, Common Terminology Criteria for Adverse Events (Version 4.0).

*

Patient No. refers to patients listed in supplemental Table 1.

Up to 24 mg/d dexamethasone for up to 5 d and/or 200 mg/m2/d cyclophosphamide for up to 4 d before blinatumomab infusion.

Patient first achieved remission on study day 99 and had to restart cycle 1 after interruptions.

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