Trial · NCT07892027
Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
NCT07892027, Phase 2, Recruiting, University of Michigan Rogel Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy. Trials, record NCT07892027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892027
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
- NCT number
- NCT07892027
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Mantle Cell Lymphoma
- Interventions
- Axicabtagene Ciloleucel, Biospecimen Collection, Brexucabtagene Autoleucel, Computed Tomography, Cyclophosphamide, Fludarabine, Natalizumab, Positron Emission Tomography
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of chimeric antigen receptor therapy (CAR-T)-associated neurotoxicity (immune effector cell associated neurotoxicity syndrome [ICANS]) | Up to CAR-T day +28 | Any grade per American Society for Transplantation and Cellular Therapy Cytokine Release Syndrome (ASTCT) criteria. Will be considered binary and the rate will be defined as number of patients without ICANS of any grade divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
| Secondary | Occurrence of severe CAR-T-associated neurotoxicity (ICANS of grade 3 or greater) | Up to CAR-T day +28 | Defined by ASTCT consensus criteria. Will be considered binary and the rate will be defined as number of patients with severe ICANS divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
| Secondary | Occurrence of severe cytokine release syndrome (cytokine release syndrome [CRS] of grade 3 or greater) | Up to CAR-T day +28 | Defined by ASTCT consensus criteria. Will be considered binary, and the rate will be defined as number of patients with severe CRS divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
| Secondary | Occurrence of adverse events related to natalizumab | Up to CAR-T day +28 | Treatment emergent adverse events will be tabulated, and the rate will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
| Secondary | Occurrence of complete response or partial response | At CAR-T day +60 | Assessed per Lugano classification on day +60 positron emission tomography/computed tomography. Will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
| Secondary | Occurrence of serious adverse events related to natalizumab | Up to CAR-T day +28 | Treatment emergent serious adverse events will be tabulated, and the rate will be defined as number of patients with treatment emergent adverse events divided by the number of evaluable patients. These rates will be reported along with the 95% exact binomial confidence interval. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07892027
GET https://conductscience.org/api/trials/v1/NCT07892027/registered