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

Primary Purpose

Pediatric ALL, B Cell, Minimal Residual Disease

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Blinatumomab for Injection

About this trial

This is an interventional treatment trial for Pediatric ALL, B Cell

Eligibility Criteria

0 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab Treatment

Arm Description

Outcomes

Primary Outcome Measures

Safety evaluation including cytokine release syndrome

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

Secondary Outcome Measures

Complete MRD response status after 1 cycle of blinatumomab

Hematologic Relapse-Free Survival (RFS)

Overall Survival (OS)

Full Information

NCT ID

NCT04604691

First Posted

October 21, 2020

Last Updated

February 20, 2022

Sponsor

Seoul National University Hospital

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT04604691

Brief Title

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

Official Title

Blinatumomab for Minimal Residual Disease Before Hematopoietic Stem Cell Transplantation With Pediatric B-cell Precursor Acute Lymphoblastic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2022 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric ALL, B Cell, Minimal Residual Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blinatumomab Treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Blinatumomab for Injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety evaluation including cytokine release syndrome

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Complete MRD response status after 1 cycle of blinatumomab

Time Frame

28 Days

Title

Hematologic Relapse-Free Survival (RFS)

Time Frame

24 Months

Title

Overall Survival (OS)

Time Frame

24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyoung Jin Kang, MD

Phone

+82-2-2072-3452

kanghj@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyoung Jin Kang, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyoung Jin Kang, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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