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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia

In brief

The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.

Key facts

Study ID

NCT07134088

Run by

Amgen

People needed

104

Starts

2025-12-08

Expected to finish

2030-06-18

Last updated by the study team

2026-05-15

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Lucile Packard Childrens Hospital Stanford — Palo Alto, California, United States
• Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St Jude Childrens Research Hospital — Memphis, Tennessee, United States
• Seattle Childrens Hospital — Seattle, Washington, United States
• Kanagawa Childrens Medical Center — Yokohami-shi, Kanagawa, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.