Preventing neurotoxicity in leukemia treatment with intrathecal chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.