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Study of Subcutaneous Blinatumomab for Childhood B-Cell ALL

This study is testing a medicine called blinatumomab, given as a shot under the skin, for children with a type of blood cancer called B-cell precursor acute lymphoblastic leukemia (ALL). This is for children whose cancer has come back or hasn't responded to previous treatments (relapsed/refractory) and still has a small amount of cancer cells (minimal residual disease positive, MRD+). The main goal is to see how safe blinatumomab is and how well it works in children under 12 years old. The study plans to enroll 104 participants. The study status is currently unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 104 participants.
What's involved
Participants will receive blinatumomab as a subcutaneous (under the skin) injection for up to 5 cycles, with each cycle lasting 35 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 7 months, and serious side effects for up to 2 years and 7 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07134088

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Active, Not Recruiting
PHASE1Ages 28+InterventionalTreatment
Amgen
~104 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Blinatumomab

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Measured over Up to 29 days
+6 more outcomes measured

Conditions

Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

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Precursor B-cell acute lymphoblastic leukemia

NCT07134088

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

  • Kanagawa Childrens Medical Center

    Yokohami-shi, Kanagawa, Japanno site contact published

  • Lucile Packard Childrens Hospital Stanford

    Palo Alto, Californiano site contact published

  • Seattle Childrens Hospital

    Seattle, Washingtonno site contact published

  • St Jude Childrens Research Hospital

    Memphis, Tennesseeno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Age ≥28 days to \<12 years at the time of informed consent/assent.
Lansky Performance Status (LPS) of ≥ 50%.
For Phase 1b and Phase 2 cohort in participants with R/R B-ALL:
Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT).
Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM.
For Phase 2 cohort in participants with MRD+ B-ALL:
Participants with MRD+ B-ALL must have between ≥ 0.1% and \< 5% blasts in the BM.
Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended \>4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications.
Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

Exclusion

Active ALL in the CNS.
History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (≥ grade 3) CNS events including immune effector cell-associated neurologic syndrome (ICANS) from prior CAR-T or other T-cell engager therapies.
Isolated EM disease.
Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
Patients with Down Syndrome are not eligible for this study.
Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
Presence of an acute or uncontrolled chronic infection, or any other concurrent disease or medical condition that could be worsened by the treatment or interfere with the participant's ability to comply with the study protocol.
Allogeneic HSCT within 12 weeks before the start of blinatumomab.

What this trial measures

  • Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)Up to 29 days
  • Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)Up to approximately 7 months
  • Phase 1b: Number of Participants who Experienced Serious TEAEsUp to 2 years and 7 months
  • Phase 1b: Number of Participants who Experienced Treatment-related TEAEsUp to approximately 7 months
  • Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)Up to approximately 7 months
  • Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 CyclesUp to 70 days
  • Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 CyclesUp to 70 days

    MRD negative response = MRD level \< 10\^-4 (0.01%).