Study on Subcutaneous Blinatumomab for Children with Difficult or Returning B-Cell Precursor Acute Lymphoblastic Leukemia

Inclusion Criteria

• Children aged 28 days to under 12 years.
• Must have a Lansky Performance Status score of 50% or higher, indicating they are able to carry out normal activities with some help.
• For children with relapsed or refractory B-ALL:
  • Leukemia has returned after or is not responding to any previous treatments, including stem cell transplants.
  • Must have 5% or more leukemia cells in the bone marrow.
• For children with minimal residual disease (MRD) positive B-ALL:
  • Must have between 0.1% and less than 5% leukemia cells in the bone marrow.
• Previous treatment with CD19-directed therapy is allowed if it ended more than 4 weeks before starting this study and there were no serious brain-related side effects.
• Children with Philadelphia chromosome-positive leukemia who cannot tolerate or do not respond to previous specific treatments are eligible.

Exclusion Criteria

• Active leukemia in the brain or spinal cord.
• History of serious brain or nervous system conditions, such as epilepsy, seizures, stroke, or severe brain injuries.
• Leukemia that is only outside the bone marrow.
• Current or past autoimmune diseases that could affect the brain or spinal cord.
• Children with Down Syndrome cannot participate.
• Active graft versus host disease requiring treatment with immune-suppressing drugs.
• Known infection with HIV or chronic hepatitis B or C.
• Any active or uncontrolled infection or other medical condition that could be worsened by the treatment or interfere with participation in the study.
• Stem cell transplant within 12 weeks before starting blinatumomab.