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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04604691
• Collaborator: Amgen (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 33.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Feb 18, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Primary Outcome Measures

1. Safety evaluation including cytokine release syndrome [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 [28 Days]

2. Hematologic Relapse-Free Survival (RFS) [24 Months]

3. Overall Survival (OS) [24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital
• Amgen

Investigators

• Principal Investigator: Hyoung Jin Kang, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04604691
• Other Study ID Numbers: 20197007
• First Posted: Oct 27, 2020
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• 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: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual; Blinatumomab

Study Results

No Results Posted as of Mar 8, 2022