Loading clinical trials...

COMPLETEDPHASE1

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

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)

NCT06649006•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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Japanese adult participants ≥ 18 years and ≤ 70 years at enrollment.
•Participant should have newly diagnosed B-cell precursor (BCP)
•Philadelphia-negative ALL in CR/CRh after induction/consolidation therapy with any MRD (+ or -).
•CR/CRh as defined in Section 11.10, Appendix 10 after induction and at any time during consolidation chemotherapy with ALL MRD2008/2019/2023 protocol regimen or 3 blocks of Hyper-CVAD.
•Bone marrow function as defined below:
•* Absolute neutrophil count (ANC) (Neutrophils) ≥500/μL
•* Platelets ≥50.000/μL (transfusion permitted)
•Adequate renal and hepatic function:
•* Total bilirubin (TBL) ≤ 2.0 x upper limit of normal (ULN) (ULN; unless Gilbert's Disease or if liver involvement with leukemia)
•* Creatinine clearance ≥50 mL/min/1.73 m\^2
+1 more criteria

Exclusion Criteria

•Disease Related
•Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening CSF demonstrates leukemic blasts, participants must receive intrathecal treatment and demonstrate negative CSF before enrollment and starting blinatumomab infusion.
•Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol-specified therapy.
•Other Medical Conditions
•History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or movement disorders).
•Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
•Active uncontrolled infection requiring therapy.
•History of other malignancy within the past 3 years, with the following exceptions:
•* Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
•* Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
+18 more criteria

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

Key Dates

Start Date

January 8, 2025

Primary Completion Date

July 30, 2025

Completion Date

December 4, 2025

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

B-precursor Acute Lymphoblastic Leukemia

Interventions

Blinatumomab

DRUG

GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

NCT04601584

B-precursor Acute Lymphoblastic LeukemiaALL+1 more

View study

COMPLETEDPHASE1/PHASE2

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

NCT02614066

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions