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COMPLETED
NCT06649006
PHASE1

Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL.

Official title: A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-01-08

Completion Date

2025-12-04

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

Blinatumomab

IV infusion

Locations (6)

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

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan