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Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Blinatumomab
Sponsored by
Northside Hospital, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia
  • Adequate renal and hepatic function
  • Negative for HIV
  • Negative serum pregnancy test, if applicable
  • ECOG 0-2

Exclusion Criteria:

  • Active CNS involvement by ALL
  • Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)
  • Contraindication to receive intrathecal methotrexate
  • Prior treatment with blinatumomab
  • Active malignancy other than ALL
  • Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator

Sites / Locations

  • Northside HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrathecal chemotherapy before blinatumomab

Arm Description

Outcomes

Primary Outcome Measures

Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Record occurrence and severity of neurotoxicity based on CTCAE criteria

Secondary Outcome Measures

Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy
Record occurrence and severity of cytokine release syndrome based on CTCAE criteria
Number of participants with a response of complete remission and MRD negativity at the end of cycle 1
Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment

Full Information

First Posted
August 25, 2022
Last Updated
August 25, 2023
Sponsor
Northside Hospital, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05519579
Brief Title
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Official Title
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northside Hospital, Inc.

4. Oversight

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

5. Study Description

Brief Summary
Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal chemotherapy before blinatumomab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Intervention Description
Blinatumomab 28ug/day continuous infusion for 4 weeks
Primary Outcome Measure Information:
Title
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Description
Record occurrence and severity of neurotoxicity based on CTCAE criteria
Time Frame
28 days after first infusion
Secondary Outcome Measure Information:
Title
Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy
Description
Record occurrence and severity of cytokine release syndrome based on CTCAE criteria
Time Frame
28 days after first infusion
Title
Number of participants with a response of complete remission and MRD negativity at the end of cycle 1
Description
Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment
Time Frame
28 days after first infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia Adequate renal and hepatic function Negative for HIV Negative serum pregnancy test, if applicable ECOG 0-2 Exclusion Criteria: Active CNS involvement by ALL Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder) Contraindication to receive intrathecal methotrexate Prior treatment with blinatumomab Active malignancy other than ALL Active infection or any other concurrent disease or medical condition that was 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
Caitlin Guzowski
Phone
404-851-8523
Email
caitlin.guzowski@northside.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Guzowski, MBA, MHA
Phone
404-851-8523
Email
caitlin.guzowski@northside.com
First Name & Middle Initial & Last Name & Degree
H. Kent Holland, MD
First Name & Middle Initial & Last Name & Degree
Asad Bashey, MD
First Name & Middle Initial & Last Name & Degree
Lawrence E Morris, MD
First Name & Middle Initial & Last Name & Degree
Scott Solomon, MD
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
First Name & Middle Initial & Last Name & Degree
Lizamarie Bachier-Rodriguez, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

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