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

NCT06649006 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20230258
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

B-precursor Acute Lymphoblastic Leukemia

Keywords

Leukemia; Blincyto®; Blinatumomab; B-precursor Acute Lymphoblastic Leukemia; B-ALL

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. A serious AE (SAE) is defined as any untoward medical occurrence that is: immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect.

  Up to approximately 31 weeks

• Number of Participants Experiencing Adverse Events of Interest (EOI)

  Up to 31 weeks

Secondary Outcomes (5)

• Steady-state Concentration (Css) of Blinatumomab

  Day 1 pre-dose, 2 and 6 hours post-dose on Day 1, Day 2, Day 3, Day 29

• Clearance (CL) of Blinatumomab

  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

  Cycles 1-4: Day 29 (each cycle is 6 weeks)

• Number of Participants Achieving Hematologic Complete Remission (CR)

  Cycles 1-4: Day 29 (each cycle is 6 weeks)

• Number of Participants Achieving Hematologic CR with Partial Peripheral Count Recovery (CRh)

  Cycles 1-4: Day 29 (each cycle is 6 weeks)

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Participants affected by B-ALL will receive blinatumomab as an intravenous (IV) infusion.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

IV infusion

Also known as: Blincyto®

Blinatumomab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (6)

Akita University Hospital

Akita, Akita, 010-8543, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Leukemia

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: January 8, 2025
• Primary Completion: July 30, 2025
• Study Completion: December 4, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

JP (6)