Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Study Details
The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
Protocol Summary
Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest
Timeframe: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest
Timeframe: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Cycle 1: Incidence of any adverse events requiring hospitalization
Timeframe: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)
Cycle 2: Incidence of any adverse events requiring hospitalization
Timeframe: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Time (in minutes) from first onset of fever, hypotension, hypoxia, other grade 3 or 4 vital sign including seizure or neurological change (grade 3-limiting self-care activities of daily living to therapeutic intervention
Timeframe: Day 1 to 3 of Cycle 1, and Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)
Incidence of treatment emergent Adverse events
Timeframe: Up to 6 months
Incidence of Adverse events of Special interest
Timeframe: Up to 6 Months
Severity of treatment emergent adverse events
Timeframe: Up to 6 months
Severity of adverse events of special interest
Timeframe: Up to 6 months
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Timeframe: Prior to treatment on Day 1 of Cycle 1 and 2 (each cycle is 6 weeks)
Incidence of treatment emergent adverse events that resulted in hospitalizations
Timeframe: Up to 6 months
Incidence of treatment emergent adverse events that resulted in surgeries
Timeframe: Up to 6 months
Incidence of treatment emergent adverse events that resulted in the use of concomitant medications
Timeframe: Up to 6 months
Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.
Timeframe: Up to 6 months