Emapalumab Prevention of CAR-T Cell Associated Toxicities
NCT Number: NCT06550141
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Large B-cell Lymphoma|Relapsed Non-Hodgkin Lymphoma|Refractory Non-Hodgkin Lymphoma|Diffuse Large B Cell Lymphoma|Primary Mediastinal Large B-cell Lymphoma|High-grade B-cell Lymphoma|Follicular Lymphoma
Interventions: DRUG: Emapalumab|DRUG: Cyclophosphamide|DRUG: Fludarabine Phosphate|DRUG: Axicabtagene Ciloleucel
Sponsor: Marcela V. Maus, M.D.,Ph.D.
Collaborators: Swedish Orphan Biovitrum
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08-01
Locations: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).

The research study involves the following study interventions:

* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)
* Axicabtagene Ciloleucel
* Emapalumab

Primary Outcome Measures: Incidence of grade 2+ CRS per ASTCT, Assessed using American Society for Transplantation and Cellular Therapy (ASTCT). All participants will be monitored and assessed for grade 2+ cytokine release syndrome (CRS) for 24 months after post treatment., Day -1 to 24 months post treatment
Secondary Outcome Measures: Rate and severity of ICANS as per ASTCT, Assessed using American Society for Transplantation and Cellular Therapy (ASTCT). The rate and severity of immune cell associated neurotoxicity syndrome (ICANS) within the first 30 days of infusion., 30 days|Objective response rate (ORR), The incidence of either a complete response or a partial response by Lugano. All subjects that do not meet the criteria for an objective response by the analysis data cutoff date will be considered non-responders., Day -1 to 24 months post treatment
Other Outcome Measures: Duration of response (DOR), Among subject who experience an objective response the date of their first objective response to disease progression per Lugano or death regardless of cause. Subjects not meeting the criteria for progression or death by the analysis data cutoff date will be censored at their last evaluable disease assessment date and their response will be noted as ongoing., From First Objective Response until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment|Progression-free Survival (PFS), The time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano or death from any cause. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date., From Day 0 until date of first documented disease progression or date of death from any cause, assessed up to 24 months post treatment|Overall survival (OS), The time from axicabtagene ciloleucel infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date., From Day 0 until documented date of death from any cause, assessed up to 24 months post treatment