Summary of treatment withdrawals and number of O-FC courses completed
Number of courses received and reason for treatment withdrawal . | No. of patients . | ||
---|---|---|---|
Ofatumumab 500 mg (n = 31) . | Ofatumumab 1000 mg (n = 30) . | Total (N = 61) . | |
Did not receive 6 courses of O-FC | 9 | 13 | 22 |
Received 3 or fewer courses of O-FC due to: | |||
Cytopenias | 2 | 3 | 5 |
AIHA | 1 | 1 | |
Nonresponse | 2 | 1 | 3 |
Patient request | 1 | 1 | |
Myocardial infarction | 1 | 1 | |
Chest discomfort | 1 | 1 | |
Death | 1 | 1 | |
Received 4-5 courses of O-FC due to: | |||
Cytopenias | 1 | 4* | 5* |
AIHA | 1 | 1 | 2 |
Investigator decision | 1 | 1 | |
Patient request | 1 | 1 |
Number of courses received and reason for treatment withdrawal . | No. of patients . | ||
---|---|---|---|
Ofatumumab 500 mg (n = 31) . | Ofatumumab 1000 mg (n = 30) . | Total (N = 61) . | |
Did not receive 6 courses of O-FC | 9 | 13 | 22 |
Received 3 or fewer courses of O-FC due to: | |||
Cytopenias | 2 | 3 | 5 |
AIHA | 1 | 1 | |
Nonresponse | 2 | 1 | 3 |
Patient request | 1 | 1 | |
Myocardial infarction | 1 | 1 | |
Chest discomfort | 1 | 1 | |
Death | 1 | 1 | |
Received 4-5 courses of O-FC due to: | |||
Cytopenias | 1 | 4* | 5* |
AIHA | 1 | 1 | 2 |
Investigator decision | 1 | 1 | |
Patient request | 1 | 1 |
AIHA indicates autoimmune hemolytic anemia.
Two patients in the 1000-mg cohort received all 6 infusions of ofatumumab but no fludarabine and cyclophosphamide during treatment course 6 due to cytopenias.