None listed
Conditions
Interventions
Drug : Patients will receive blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion at
constant flow rate for four weeks, followed by a two-week infusion free interval, defined as
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Immunophenotypic evidence of CD19 positive B-precursor ALL 2. Age <18 years at the time of informed consent/assent 3. B-cell precursor ALL in first or later hematologic complete remission (CR) defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks 4. Persistent or recurrent MRD =10-4 in an assay with a minimum sensitivity of 10-5 before hematopoietic stem cell transplantation 5. Bone marrow function as defined below: • Absolute neutrophil count =1,000/µL • Platelets =50,000/µL (transfusion permitted) • Hemoglobin level =9 g/dL (transfusion permitted) 6. Renal and hepatic function as defined below: • AST, ALT, and AP < 2 x upper limit of normal (ULN) • Total bilirubin <1.5 x ULN • Creatinine clearance =50mL/min 7. Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test 8. Negative pregnancy test in women of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Presence of circulating blasts or current extramedullary involvement by ALL 2. History of relevant CNs pathology or current relevant CNS pathology (e.g. seizure, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis) with the except of CNS leukemia that is well controlled with intrathecal therapy 3. Current infiltration of cerebrospinal fluid by ALL 4. History of or active relevant autoimmune disease 5. Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis) 6. Radiotherapy within 4 weeks prior to study treatment 7. Autologous HSCT within six weeks prior to study treatment 8. Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment 9. Treatment with any investigational product within 4 weeks prior to study treatment 10. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation 11. Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix 12. Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters are assessed regularly during screening, treatment, and follow-up periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Assessment of Blinatumomab (Complete MRD Response) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyoungJin Kang
Seoul National University Hospital
Outcome results
None listed