The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
IV infusion
Akita University Hospital
Akita, Akita, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs are any events that occurred after the participant received trial treatment. A serious TEAE was defined as any untoward medical occurrence that: was immediately life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically important serious event. Treatment-related TEAEs were any AEs that could be considered attributable to the trial treatment.
Time frame: From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days
Number of Participants Experiencing Adverse Events of Interest (EOI)
An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were any events that occurred after the participant received trial treatment.
Time frame: From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days
Steady-state Concentration (Css) of Blinatumomab
Time frame: Cycle 1: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29; Cycle 2: Day 1 pre-dose, and Days 2 and 29; Cycles 3 and 4: Day 1 pre-dose, and Day 29
Clearance (CL) of Blinatumomab
Time frame: Cycle 1: Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29; Cycle 2: Day 1 pre-dose, and Days 2 and 29; Cycles 3 and 4: Day 1 pre-dose, and Day 29
Number of Participants Achieving Minimal Residual Disease (MRD) After Each Cycle of Blinatumomab
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Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Time frame: Cycles 1-4: Day 29 (each cycle is 42 days)
Number of Participants Achieving Hematologic CR
Time frame: Cycles 1-4: Day 29 (each cycle is 42 days)
Number of Participants Achieving Hematologic CR With Partial Peripheral Count Recovery (CRh)
Time frame: Cycles 1-4: Day 29 (each cycle is 42 days)