InO dose escalation and de-escalation schedule
Dose level . | IV InO dose (mg/m2) . | |||||||
---|---|---|---|---|---|---|---|---|
Course 1 . | Courses 2-6* . | |||||||
Day 1 . | Day 8 . | Day 15 . | Total doses per course . | Day 1 . | Day 8† . | Day 15† . | Total doses per course . | |
–2 | 0.4 | 0.2 | 0.2 | 0.8 | 0.2 | 0.2 | 0.2 | 0.6 |
–1 | 0.5 | 0.3 | 0.3 | 1.1 | 0.3 | 0.3 | 0.3 | 0.9 |
+1 (start) | 0.6 | 0.4 | 0.4 | 1.4 | 0.4 | 0.4 | 0.4 | 1.2 |
+2 | 0.8 | 0.5 | 0.5 | 1.8 | 0.5 | 0.5 | 0.5 | 1.5 |
+3 | 1.0 | 0.6 | 0.6 | 2.2 | 0.6 | 0.6 | 0.6 | 1.8 |
Dose level . | IV InO dose (mg/m2) . | |||||||
---|---|---|---|---|---|---|---|---|
Course 1 . | Courses 2-6* . | |||||||
Day 1 . | Day 8 . | Day 15 . | Total doses per course . | Day 1 . | Day 8† . | Day 15† . | Total doses per course . | |
–2 | 0.4 | 0.2 | 0.2 | 0.8 | 0.2 | 0.2 | 0.2 | 0.6 |
–1 | 0.5 | 0.3 | 0.3 | 1.1 | 0.3 | 0.3 | 0.3 | 0.9 |
+1 (start) | 0.6 | 0.4 | 0.4 | 1.4 | 0.4 | 0.4 | 0.4 | 1.2 |
+2 | 0.8 | 0.5 | 0.5 | 1.8 | 0.5 | 0.5 | 0.5 | 1.5 |
+3 | 1.0 | 0.6 | 0.6 | 2.2 | 0.6 | 0.6 | 0.6 | 1.8 |
After course 1, in patients who have achieved a CR, the day 1 dose is decreased slightly because of no loading dose requirement. In patients who have not yet achieved a CR after course 1, a loading dose similar to that in course 1 was given in course 2, but not in subsequent courses.
Visit window of ±1 day.