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B Precursor Acute Lymphoblastic LeukemiaPhase 2NCT06054113

Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

A Phase 2 study testing Blinatumomab in people with B Precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia, run by Amgen at 7 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy of blinatumomab. Read more about this study

Who is it for?
Ages 1 month to 204 months
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
18 participants
Where
7 sitesChina
Study dates
23 Jul 2024to 14 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 1 month to 204 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participant's parent or legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated
  • Pediatric participants aged > 1 month and < 18 years at the time of informed consent
  • Relapsed or/refractory precursor B-cell acute lymphoblastic leukemia (ALL) disease, defined as ≥5% bone marrow blasts with at least one of the following:
  • Second or later bone marrow relapse;
  • Any marrow relapse after allogeneic hematopoietic stem cell transplant (alloHSCT);
  • Refractory to other treatments:
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  • For participants in first relapse: failure to achieve a complete remission (CR) following a full standard reinduction chemotherapy regimen
  • For participants who have not achieved a first remission, failure to achieve remission following a full standard induction regimen
  • Karnofsky performance status ≥ 50% for participants ≥ 16 years
  • Lansky performance status ≥ 50% for participants < 16 years

Who cannot join

  • Evidence of current central nervous system (CNS) involvement by ALL. Participants with CNS disease at the time of relapse are eligible if CNS is successfully treated prior to enrollment.
  • Other Medical Conditions
  • Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy).
  • Isolated extramedullary (EM) disease.
  • Active malignancy other than ALL.
  • Burkitt's leukemia according to the World Health Organization (WHO) 2016 criteria.
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  • Abnormal renal or hepatic function at screening as defined below:
  • Abnormal serum creatinine based on age/gender as described by Threshold Creatinine Values
  • Direct bilirubin > 1.5 mg/dl (25.6 μmol/L) at screening (unless related to Gilbert's or Meulengracht disease).
  • Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.
  • Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive).
  • Known hypersensitivity to blinatumomab or any of the products or components of the blinatumomab formulation.
  • Prior/Concomitant Therapy
  • AlloHSCT within 12 weeks prior to start of protocol-specified therapy.
  • Active acute or chronic Graft-versus-Host-Disease (GvHD) requiring systemic treatment with immunosuppressive medication.
  • Radiotherapy within 2 weeks prior to start of protocol-specified therapy.
  • Immunotherapy (eg, rituximab) within 4 weeks prior to start of protocol-specified therapy. Prior failed cluster of differentiation 19 (CD19) directed therapy such as prior blinatumomab or CD19 chimeric antigen receptor T cells (CAR T cell) will be allowed (with demonstrated continued CD19+ expression) if treatment ended > 4 weeks prior to start of protocol-specified therapy.
  • Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy. With the exception of intrathecal chemotherapy and/or low dose maintenance therapy for example vinca alkaloids, mercaptopurine, methotrexate, or hydroxyurea or pre-phase chemotherapy and/or dexamethasone. Any low dose chemotherapy as stated above must be discontinued before starting pre-phase.
  • Prior/Concurrent Clinical Study Experience
  • Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Other Exclusions
  • Female participants of childbearing potential with a positive pregnancy test assessed at Screening by a highly sensitive urine or serum pregnancy test.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
  • Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of protocol-required therapy with highest teratogenic risk.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
  • Female participants planning to become pregnant while on study through 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of protocol-required treatment with highest teratogenic risk.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Childrens Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400015

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Shanghai Children's Medical Center

    Shanghai, Shanghai Municipality, 200127

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, 215002

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Wuhan Childrens Hospital

    Wuhan, Hubei, 430015

Other trials in China

About this study

Official title: An Open-label, Multicenter, Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics (PK) of Blinatumomab in Chinese Pediatric Subjects With Relapsed or Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

The primary objective of this study is to evaluate the efficacy of blinatumomab.

Being tested
Blinatumomab
Keywords
Relapsed/Refractory B precursor Acute Lymphoblastic Leukemia, R/R B-ALL, Blinatumomab
Medical subject headings
Recurrence

What participants receive

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

  • BlinatumomabDrug

    Also called Blincyto®

    Administered via CIVI

Study groups in NCT06054113
Study groupRoleWhat they receive
BlinatumomabExperimentalParticipants will receive up to 5 cycles of blinatumomab (cycle is 42 days), including a 28-day continuous intravenous infusion (CIVI) of blinatumomab and a 14-day treatment free interval.
Receives: Drug: Blinatumomab

What is being measured

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

  1. Number of Participants with Complete Remission (CR)

    Measured: Up to 84 days

  2. Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)

    Measured: Up to 84 days

Secondary outcomes (12)

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 240 days

  2. Number of Participants with Serious TEAEs

    Measured: Up to approximately 2 years

  3. Number of Participants with Treatment-related TEAEs

    Measured: Up to approximately 240 days

  4. Number of Participants with Adverse Events of Interest

    Measured: Up to approximately 240 days

  5. Steady State Concentration (Css) of Blinatumomab

    Measured: Days 3, 8, 9 and 29

  6. Clearance of Blinatumomab

    Measured: Days 3, 8, 9 and 29

  7. Overall Survival (OS) Rate

    Measured: Up to approximately 2 years

  8. Relapse-Free Survival (RFS) Rate

    Measured: Up to approximately 2 years

  9. Number of Participants who Receive Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT)

    Measured: Up to approximately 2 years

  10. 100-day Mortality Rate After alloHSCT

    Measured: Up to approximately 2 years

  11. Number of Participants with Anti-blinatumomab Antibody (ADA) Formation

    Measured: Up to approximately 240 days

  12. Minimal Residual Disease (MRD) Response

    Measured: Up to 84 days

Timeline

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

  1. First posted26 Sep 2023
  2. Study start23 Jul 2024
  3. Primary completion6 Jan 2026
  4. Study completion14 Oct 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06054113
Sponsor's protocol ID
20190359
Status last verified
Oct 2026
First submitted
18 Sep 2023
Last updated
2 Nov 2026
Results posted
No
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.

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinatumomab in people with B Precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia, run by Amgen at 7 sites in China.

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 10 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 Complete Remission (CR) (time frame: Up to 84 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 NCT06054113, which also lists 1 linked publication.

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 2 Nov 2026.

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