Trials / Recruiting
RecruitingNCT05519579
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Northside Hospital, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methotrexate | Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration |
| DRUG | Blinatumomab | Blinatumomab 28ug/day continuous infusion for 4 weeks |
Timeline
- Start date
- 2023-06-30
- Primary completion
- 2026-11-01
- Completion
- 2026-12-01
- First posted
- 2022-08-29
- Last updated
- 2026-04-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05519579. Inclusion in this directory is not an endorsement.