A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma
H. Lee Moffitt Cancer Center and Research Institute
Summary
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible. * Adult males or females who are 18 years of age or older at time of signing informed consent. * Must have ability to comprehend and the willingness to sign written informed consent for study participation. * Eligible to receive CAR T-cell therapy (Brexucabtagene autoleucel) for MCL by the standard of care label, which states: "TECARTUS or Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of: Adult…
Interventions
- DrugPirtobrutinib
Pirtobrutinib is a non-covalent BTKi that has preserved activity in the presence of mutations that drive BTKi resistance.
- DrugBrexucabtagene Autoleucel
Brexucabtagene autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy (brexu-cel).
Locations (3)
- Stanford Cancer CenterStanford, California
- Univ of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
- Moffitt Cancer CenterTampa, Florida