Preventing neurotoxicity in leukemia treatment with intrathecal chemotherapy
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
This study is testing if giving a specific chemotherapy directly into the spine can help protect the brain from side effects while treating adults with Acute Lymphoblastic Leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Drugs / interventions | blinatumomab, methotrexate, chemotherapy |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05519579 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of intrathecal chemotherapy to reduce neurotoxicity associated with blinatumomab therapy in adults with Acute Lymphoblastic Leukemia (ALL). By administering methotrexate before and during blinatumomab treatment, the study aims to maintain the drug's anti-leukemic effects while minimizing adverse neurological effects. Participants will be closely monitored for both efficacy and safety throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates are adults receiving their first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia with adequate organ function.
Not a fit: Patients with active CNS involvement by ALL or significant CNS disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of neurotoxicity in patients undergoing treatment for Acute Lymphoblastic Leukemia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing treatment-related neurotoxicity in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Melhem Solh, MD — Blood and Marrow Transplant Group of Georgia
- Study coordinator: Caitlin Guzowski
- Email: caitlin.guzowski@northside.com
- Phone: 404-851-8523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.