Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Purpose
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.
Condition
- Acute Lymphoblastic Leukemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intrathecal chemotherapy before blinatumomab |
|
Recruiting Locations
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
More Details
- Status
- Recruiting
- Sponsor
- Northside Hospital, Inc.