Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
DRUGMethotrexate
Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
DRUGBlinatumomab
Blinatumomab 28ug/day continuous infusion for 4 weeks
Sponsors
Northside Hospital, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTCaitlin Guzowski
PRINCIPAL_INVESTIGATORMelhem Solh, MD
Blood and Marrow Transplant Group of Georgia
Outcome results
None listed