Actively Recruiting
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
Led by Amgen · Updated on 2026-04-24
104
Participants Needed
4
Research Sites
236 weeks
Total Duration
On this page
Sponsors
A
Amgen
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
CONDITIONS
Official Title
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6528 days to <12 years at the time of informed consent/assent.
- Lansky Performance Status (LPS) of 65 50%.
- For Phase 1b and Phase 2 cohort in participants with relapsed/refractory 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 is considered relapse in the bone marrow.
- For Phase 2 cohort in participants with MRD+ B-ALL: participants with MRD+ B-ALL must have between 650.1% and < 5% blasts in the bone marrow.
- Prior CD19-directed therapy allowed if treatment ended >4 weeks prior to protocol therapy start and no prior central nervous system complications.
- Any Philadelphia chromosome-positive participant intolerant or refractory to prior tyrosine kinase inhibitors are eligible.
You will not qualify if you...
- Active acute lymphoblastic leukemia in the central nervous system.
- History or presence of clinically relevant central nervous system pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (grade 653) central nervous system events including immune effector cell-associated neurologic syndrome from prior CAR-T or other T-cell engager therapies.
- Isolated extramedullary disease.
- Current or history of autoimmune disease with potential central nervous system involvement.
- Patients with Down Syndrome.
- Active acute or chronic graft versus host disease requiring systemic immunosuppressive treatment.
- Known infection with human immunodeficiency virus or chronic hepatitis B or C virus infection.
- Presence of an acute or uncontrolled chronic infection or any other concurrent disease or medical condition that could worsen with treatment or interfere with study compliance.
- Allogeneic hematopoietic stem cell transplant within 12 weeks before starting blinatumomab.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
3
Seattle Childrens Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
4
Kanagawa Childrens Medical Center
Yokohami-shi, Kanagawa, Japan, 232-8555
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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