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

April 22, 2026 updated by: Amgen

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Akita
      • Akita, Akita, Japan, 010-8543
        • Akita University Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.

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.
    • Adequately treated cervical carcinoma in situ without evidence of disease.
    • Adequately treated breast ductal carcinoma in situ without evidence of disease.
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.

Prior/Concomitant Therapy

  • Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
  • Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus. In Japan, follow the JSH Guidelines for the Management of Hepatitis B Virus Infection version 4 (The Japan Society of Hepatology, 2022) for the screening of Hepatis B virus infection.
  • Radiotherapy within 4 weeks prior to study treatment.

Prior/Concurrent Clinical Study Experience

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). This does not apply to other investigational procedures or participation in observational research studies while participating in this study are excluded.

Other Exclusions

  • Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 48 hours after the last dose of blinatumomab.
  • Participants who are breastfeeding or who plan to breastfeed while on study through 48 hours after the last dose of blinatumomab.
  • Participants planning to become pregnant or donate eggs while on study through 48 hours after the last dose of blinatumomab.
  • Participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
  • Participant has known hypersensitivity to blinatumomab or to any component of the product formulation.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blinatumomab
Participants affected by B-ALL will receive blinatumomab as an intravenous (IV) infusion.
Drug: Blinatumomab
IV infusion
Other Names:
  • Blincyto®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
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
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.
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)
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
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.
From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
Time Frame: Cycles 1-4: Day 29 (each cycle is 42 days)
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)
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)
Cycles 1-4: Day 29 (each cycle is 42 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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