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

Last updated: February 19, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Treatment

Blinatumomab

Clinical Study ID

NCT06649006
20230258
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

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 anyMRD (+ or -).

  • CR/CRh by the end of induction and 3 blocks of consolidation chemotherapy with ALLMRD2008/2019/2023 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; unlessGilbert'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

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.

Other Medical Conditions

  • History of relevant central nervous system (CNS) pathology or current relevant CNSpathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage,severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organicbrain syndrome, psychosis, or coordination or movement disorders).

  • Current autoimmune disease or history of autoimmune disease with potential CNSinvolvement.

  • 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 diseasepresent for ≥ 3 years before enrollment and felt to be at low risk forrecurrence by the treating physician.

  • Adequately treated nonmelanoma skin cancer or lentigo maligna without evidenceof 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 insitu.

Prior/Concomitant Therapy

  • Systemic cancer chemotherapy within 2 weeks prior to study treatment (except forintrathecal prophylaxis)

  • Known infection with human immunodeficiency virus (HIV) or chronic infection withhepatitis B virus or hepatitis C virus. In Japan, follow the JSH Guidelines for theManagement of Hepatitis B Virus Infection version 4 (The Japan Society ofHepatology, 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 ofcontraception during treatment and for an additional 48 hours after the last dose ofblinatumomab.

  • 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 48hours after the last dose of blinatumomab.

  • Participants of childbearing potential with a positive pregnancy test assessed atscreening by a highly sensitive urine or serum pregnancy test.

  • Participant has known hypersensitivity to blinatumomab or to any component of theproduct formulation.

  • Participant likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures (e.g.,Clinical Outcome Assessments) to the best of the participant and investigator'sknowledge.

  • History or evidence of any other clinically significant disorder, condition, ordisease (except for those outlined above) that, in the opinion of the investigatoror Amgen physician, if consulted, would pose a risk to participant safety, orinterfere with the study evaluation, procedures, or completion.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Blinatumomab
Phase: 1
Study Start date:
January 08, 2025
Estimated Completion Date:
September 28, 2025

Connect with a study center

  • Akita University Hospital

    Akita-shi, Akita 010-8543
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital

    Fukushima-shi, Fukushima 960-1295
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa-shi, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata-shi, Yamagata 990-9585
    Japan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.