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

Phase

Condition

Lymphoproliferative Disorders

Platelet Disorders

Leukemia

Treatment

Methotrexate

Blinatumomab

Clinical Study ID

NCT05519579

NSH 1354

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positiveB-cell Acute Lymphoblastic Leukemia
Adequate renal and hepatic function
Negative for HIV
Negative serum pregnancy test, if applicable
ECOG 0-2

Exclusion

Exclusion Criteria:

Active CNS involvement by ALL
Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascularischemia/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 wasdeemed to interfere with the conduct of the study as judged by the investigator

Study Design