Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthside Hospital, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Methotrexate
  • Blinatumomab

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators