RecruitingPhase 2NCT05519579
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Sponsor
Northside Hospital, Inc.
Enrollment
20 participants
Start Date
Jun 30, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
DRUGMethotrexate
Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
DRUGBlinatumomab
Blinatumomab 28ug/day continuous infusion for 4 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05519579
Related Trials
A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...
NCT056212918 locations
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
NCT0406539957 locations
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
NCT068161341 location
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
NCT074799271 location
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
NCT034227311 location