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

NCT04604691 | Unknown Phase 1 FDA Drug

• 1 other identifier: 20197007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety evaluation including cytokine release syndrome

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

  At the latest possible timepoint prior to the initiation of transplant conditioning or after 30 days of Blinatumomab treatment

Secondary Outcomes (3)

• Complete MRD response status after 1 cycle of blinatumomab

  28 Days

• Hematologic Relapse-Free Survival (RFS)

  24 Months

• Overall Survival (OS)

  24 Months

Study Arms (1)

Blinatumomab Treatment

EXPERIMENTAL

Drug: Blinatumomab for Injection

Interventions

Blinatumomab for Injection 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.

Blinatumomab Treatment

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Amgen: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

blinatumomab; Injections

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hyoung Jin Kang, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, MD

CONTACT

+82-2-2072-3452; kanghj@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: February 18, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

KR (1)