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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT05519579
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
  • Blinatumomab — DRUG
    Blinatumomab 28ug/day continuous infusion for 4 weeks

Study Details

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.

Key Dates

Start date
Jun 30, 2023
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intrathecal chemotherapy before blinatumomab

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

Locations (1)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342
Caitlin Guzowski, MBA, MHA
[email protected]
404-851-8523
H. Kent Holland, MD (SUB_INVESTIGATOR)
Asad Bashey, MD (SUB_INVESTIGATOR)
Lawrence E Morris, MD (SUB_INVESTIGATOR)
Scott Solomon, MD (SUB_INVESTIGATOR)
Melhem Solh, MD (PRINCIPAL_INVESTIGATOR)
Lizamarie Bachier-Rodriguez, MD (SUB_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Northside Hospital· Atlanta, GA

Related Studies