Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Phase 2
Recruiting
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT05519579
- Lead Sponsor
- Northside Hospital, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intrathecal chemotherapy before blinatumomab Blinatumomab - Intrathecal chemotherapy before blinatumomab Methotrexate -
- Primary Outcome Measures
Name Time Method Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy 28 days after first infusion Record occurrence and severity of neurotoxicity based on CTCAE criteria
- Secondary Outcome Measures
Name Time Method Number of participants with a response of complete remission and MRD negativity at the end of cycle 1 28 days after first infusion Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment
Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy 28 days after first infusion Record occurrence and severity of cytokine release syndrome based on CTCAE criteria
Trial Locations
- Locations (1)
Northside Hospital
🇺🇸Atlanta, Georgia, United States