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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Methotrexate

Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration

DRUG

Blinatumomab

Blinatumomab 28ug/day continuous infusion for 4 weeks

Locations (1)

Northside Hospital
Atlanta, Georgia, United States