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Trial Title:
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
NCT ID:
NCT05519579
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neurotoxicity Syndromes
Methotrexate
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab
administration
Arm group label:
Intrathecal chemotherapy before blinatumomab
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Blinatumomab 28ug/day continuous infusion for 4 weeks
Arm group label:
Intrathecal chemotherapy before blinatumomab
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Caitlin Guzowski, MBA, MHA
Phone:
404-851-8523
Email:
caitlin.guzowski@northside.com
Investigator:
Last name:
H. Kent Holland, MD
Email:
Sub-Investigator
Investigator:
Last name:
Asad Bashey, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lawrence E Morris, MD
Email:
Sub-Investigator
Investigator:
Last name:
Scott Solomon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Melhem Solh, MD
Email:
Principal Investigator
Investigator:
Last name:
Lizamarie Bachier-Rodriguez, MD
Email:
Sub-Investigator
Start date:
June 30, 2023
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Northside Hospital, Inc.
Agency class:
Other
Source:
Northside Hospital, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519579
