Natalizumab for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II studies how well natalizumab works in preventing immune effector cell associated neurologic syndrome (ICANS) in patients with diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory) receiving chimeric antigen receptor (CAR) T-cell therapy. A major complication of CAR T-cell therapy is ICANS. ICANS is inflammation of the brain or nerves. ICANS currently requires high-dose corticosteroid treatment which can inhibit CAR T-cell response. Natalizumab prevents immune cells from traveling from the blood to the fluid around the brain, which is a process thought to play a major role in CAR T-cell related brain injury. Natalizumab may be safe and effective in decreasing the frequency of severe ICANS in patients with DLBCL or MCL receiving CAR T-cell therapy.
Who Is on the Research Team?
Monalisa Ghosh
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with diffuse large B-cell lymphoma or mantle cell lymphoma that has come back or not responded to treatment, and who are about to receive CAR T-cell therapy. Participants must meet certain health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Natalizumab
Trial Overview
The study tests if adding natalizumab can help prevent brain inflammation (ICANS) in patients getting CAR T-cell therapy for specific lymphomas. Standard treatments like chemotherapy and imaging are also used as part of care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive SOC conditioning therapy consisting of fludarabine IV and cyclophosphamide IV on days -4 and -3. Patients then receive natalizumab IV over 1 hour on day -1, followed by SOC CAR T-cell therapy with axicabtagene ciloleucel or brexucabtagene autoleucel on day 0. Patients also undergo PET/CT and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.