Study Complete
Sponsor ID
20230258
Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants with Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
Study Details
The main objective of the study is to evaluate safety and tolerability of
blinatumomab in adult Japanese participants with newly diagnosed B-ALL.
Protocol Summary
Primary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 31 weeks
Number of Participants Experiencing Adverse Events of Interest (EOI)
Timeframe: Up to 31 weeks
Secondary Outcome Measures
Steady-state Concentration (Css) of Blinatumomab
Timeframe: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29
Clearance (CL) of Blinatumomab
Timeframe: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29
Number of Participants Achieving Minimal Residual Disease (MRD) After Each Cycle of Blinatumomab
Timeframe: Cycles 1-4: Day 29 (each cycle is 6 weeks)
Number of Participants Achieving Hematologic Complete Remission (CR)
Timeframe: Cycles 1-4: Day 29 (each cycle is 6 weeks)
Number of Participants Achieving Hematologic CR with Partial Peripheral Count Recovery (CRh)
Timeframe: Cycles 1-4: Day 29 (each cycle is 6 weeks)
Locations
Location
Akita University Hospital
Akita-shi, Akita, Japan, 010-8543
Status
Recruiting
Location
Fukushima Medical University Hospital
Fukushima-shi, Fukushima, Japan, 960-1295
Status
Recruiting
Location
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Status
Recruiting
Location
Kanazawa University Hospital
Kanazawa-shi, Ishikawa, Japan, 920-8641
Status
Recruiting
Location
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
Status
Recruiting
Location
Yamagata University Hospital
Yamagata-shi, Yamagata, Japan, 990-9585
Status
Recruiting