Recruiting
Phase 2

Intrathecal Chemoprophylaxis

Sponsor:

Northside Hospital, Inc.

Code:

NCT05519579

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methotrexate

Blinatumomab

Study Details

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.

Conditions

Acute Lymphoblastic Leukemia

Study ID

NCT05519579

Start date

Jun 30, 2023

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intrathecal chemotherapy before blinatumomab

Interventions

Methotrexate

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

Blinatumomab

Blinatumomab 28ug/day continuous infusion for 4 weeks

Primary outcome measure

  • Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy [ Time Frame: 28 days after first infusion ]

Central Contacts and Locations

Central contacts

Caitlin Guzowski

404-851-8523caitlin.guzowski@northside.com

Locations

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Caitlin Guzowski, MBA, MHA

404-851-8523caitlin.guzowski@northside.com

Principal Investigator:

Melhem Solh, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-20.