Blinatumomab for minimal residual disease before hematopoietic stem cell transplantation in pediatric B-cell precursor

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0006135

Enrollment

Registered

2021-05-13

Start date

2021-08-16

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In this single-arm clinical trial, all enrolled subjects will receive blinatumomab at a dose of 15 mcg/m^2/day or 28 mcg/day as continuous intravenous infusion for 28 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Immunophenotypic evidence of Cluster of Differentiation 19 (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. Confirmed MRD positivity 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 9. Performance status: Karnofsky or Lansky score =70 for subjects =16 years old or <16 years old, respectively

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
The incidence of treatment-emergent and treatment-related adverse events	—

Secondary

Measure	Time frame
Complete MRD response status after 1 cycle of blinatumomab;Hematologic Relapse-Free Survival (RFS);Overall Survival (OS)	—

Countries

Korea, Republic of

Contacts

Public ContactHyoung Jin Kang

Seoul National University Hospital

kanghj@snu.ac.kr+82-2-2072-3304

Outcome results