NCT05519579RecruitingPhase 2
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Aug 2022
- Start date
- 30 Jun 2023
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Northside Hospital, Inc.
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT05519579
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 30 Jun 2023 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with blinatumomab
- 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
Other illness
- Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)
- Active malignancy other than ALL
Other
- Active CNS involvement by ALL
- Contraindication to receive intrathecal methotrexate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.