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

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ClinicalTrials.gov Identifier: NCT04604691
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric ALL, B Cell Minimal Residual Disease Drug: Blinatumomab for Injection Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blinatumomab for Minimal Residual Disease Before Hematopoietic Stem Cell Transplantation With Pediatric B-cell Precursor Acute Lymphoblastic Leukemia
Actual Study Start Date : February 18, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Blinatumomab Treatment Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety evaluation including cytokine release syndrome [ Time Frame: At the latest possible timepoint prior to the initiation of transplant conditioning or after 30 days of Blinatumomab treatment ]
    The incidence of treatment-emergent and treatment-related adverse events


Secondary Outcome Measures :
  1. Complete MRD response status after 1 cycle of blinatumomab [ Time Frame: 28 Days ]
  2. Hematologic Relapse-Free Survival (RFS) [ Time Frame: 24 Months ]
  3. Overall Survival (OS) [ Time Frame: 24 Months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604691


Contacts
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Contact: Hyoung Jin Kang, MD +82-2-2072-3452 kanghj@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hyoung Jin Kang, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Amgen
Investigators
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Principal Investigator: Hyoung Jin Kang, MD Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04604691    
Other Study ID Numbers: 20197007
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasm, Residual
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Blinatumomab
Antineoplastic Agents