B-precursor Acute Lymphoblastic LeukemiaPhase 1NCT06649006

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

A Phase 1 study testing Blinatumomab in people with B-precursor Acute Lymphoblastic Leukemia, run by Amgen at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: B-precursor Acute Lymphoblastic Leukemia
What is being tested?: Blinatumomab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 6 sitesJapan
Study dates: 8 Jan 2025to 4 Dec 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

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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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

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

Other trials in Japan

About this study

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)

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
Being tested: Blinatumomab
Keywords: Leukemia, Blincyto®, Blinatumomab, B-precursor Acute Lymphoblastic Leukemia, B-ALL
Medical subject headings: Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BlinatumomabDrug
Also called Blincyto®
IV infusion

Study groups in NCT06649006
Study group	Role	What they receive
Blinatumomab	Experimental	Participants affected by B-ALL will receive blinatumomab as an intravenous (IV) infusion. Receives: Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
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.
Measured: 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)
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.
Measured: 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 outcomes (5)

Steady-state Concentration (Css) of Blinatumomab
Measured: 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
Measured: 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
Measured: Cycles 1-4: Day 29 (each cycle is 42 days)
Number of Participants Achieving Hematologic CR
Measured: Cycles 1-4: Day 29 (each cycle is 42 days)
Number of Participants Achieving Hematologic CR With Partial Peripheral Count Recovery (CRh)
Measured: Cycles 1-4: Day 29 (each cycle is 42 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 20254 Dec 2025

First posted18 Oct 2024
Study start8 Jan 2025
Primary completion30 Jul 2025
Study completion4 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for B-precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06649006
Sponsor's protocol ID: 20230258
Status last verified: Apr 2026
First submitted: 17 Oct 2024
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06649006
Acronym / sponsor ID: 20230258
Conditions: B-precursor Acute Lymphoblastic Leukemia
Keywords: Leukemia, Blincyto®, Blinatumomab, B-precursor Acute Lymphoblastic Leukemia, B-ALL
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 8 Jan 2025 (actual)
Primary completion: 30 Jul 2025 (actual)
Study completion: 4 Dec 2025 (actual)
First posted: 18 Oct 2024 (actual)
Results: Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blinatumomab	Experimental	Drug: BlinatumomabParticipants affected by B-ALL will receive blinatumomab as an intravenous (IV) infusion.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (28 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BlinatumomabAlso: Blincyto®IV infusion	Drug	Blinatumomab

Primary outcome

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.
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.

5 secondary outcomes

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
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
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)
Number of Participants Achieving Hematologic CR
Time frame: 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)

Results and safety

Results posted to the registry on 13 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evaluable Participants: Blinatumomab	5	2
Non-evaluable Participants: Blinatumomab	1	1

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Evaluable Participants: Blinatumomab n = 5	Non-evaluable Participants: Blinatumomab n = 1
TEAEs	5	1
Serious TEAEs	1	0
Treatment-related TEAEs	3	1

Population analysed: The safety analysis set included all participants that were enrolled and received at least one dose of blinatumomab.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Evaluable Participants: Blinatumomab n = 5	Non-evaluable Participants: Blinatumomab n = 1
Value	2	1

Population analysed: The safety analysis set included all participants that were enrolled and received at least one dose of blinatumomab.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: For AE reporting: from first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days. For all-cause mortality reporting: from enrolment until end of trial; median [min, max] duration was 44 (16, 94) days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evaluable Participants: Blinatumomab	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Non-evaluable Participants: Blinatumomab	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Blinatumomab in people with B-precursor Acute Lymphoblastic Leukemia, run by Amgen at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.