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

NCT ID: NCT04604691

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Pediatric ALL, B Cell; Minimal Residual Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blinatumomab Treatment

Group Type: EXPERIMENTAL

Blinatumomab for Injection

Intervention Type: DRUG

Blinatumomab will be administered as a continuous intravenous (CIV) infusion at a constant flow rate over four weeks followed by a two-week infusion free interval.

Interventions

Blinatumomab for Injection

Blinatumomab will be administered as a continuous intravenous (CIV) infusion at a constant flow rate over four weeks followed by a two-week infusion free interval.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyoung Jin Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyoung Jin Kang, MD

Role: CONTACT

kanghj@snu.ac.kr

+82-2-2072-3452

Facility Contacts

Hyoung Jin Kang, MD, PhD

Role: primary

Other Identifiers

20197007

Identifier Type: -

Identifier Source: org_study_id