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)

Sponsor ID
20230258
Clinicaltrials.gov ID
NCT06649006
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
6
Additional Study Details

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
Status
Contact Us
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