Blinatumomab in Pediatric B-cell Acute Lymphoblastic Leukemia (ALL) With Minimal Residual Disease (MRD)

Seoul National University

Status and phase

Enrolling

Phase 1

Conditions

Pediatric ALL, B Cell

Minimal Residual Disease

Treatments

Drug: Blinatumomab for Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04604691

20197007

Details and patient eligibility

About

This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.

Enrollment

20 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Immunophenotypic evidence of Cluster of Differentiation 19 (CD19) positive B precursor ALL
Age <18 years at the time of informed consent/assent
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
Persistent or recurrent MRD ≥10^-4 in an assay with a minimum sensitivity of 10^-5 before hematopoietic stem cell transplantation
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)
Renal and hepatic function as defined below: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase (AP) < 2 x upper limit of normal (ULN), Total bilirubin <1.5 x ULN, Creatinine clearance ≥ 50 mL/min
Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test
Negative pregnancy test in women of childbearing potential

Exclusion criteria

Presence of circulating blasts or current extramedullary involvement by ALL
History of relevant central nervous system (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
Current infiltration of cerebrospinal fluid by ALL
History of or active relevant autoimmune disease
Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
Radiotherapy within 4 weeks prior to study treatment
Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to study treatment
Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
Treatment with any investigational product within 4 weeks prior to study treatment
Known hypersensitivity to immunoglobulin or to any other component of the study drug formulation
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
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