Table 3.

Stopping boundaries for Data Safety and Monitoring Committee

FIRST study cohort
No. of participants completed 6-month assessment	Stop if N with CR at 6 months is equal to or less than:	Stop if N with ACE at 6 months is equal to or greater than:
10	0	4
20	2	5
30	3	6
40	6	7
50	8	8

NEXT study cohort
Number of participants treated and completed 6-month assessment	Stop if number with ORR at 6 months is equal to or less than:	Stop if number with ACE at 6 months is equal to or greater than:
10	0	4
20	2	6
30	4	8
40	6	10
50	8	11

ACE, acquired clonal evolution.