A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
M.D. Anderson Cancer Center
Summary
To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.
Description
Primary Objectives * To evaluate the safety of axicabtagene ciloleucel (axi-cel) and glofitamab as combination therapy in 2nd line LBCL participants * To evaluate the effect of axi-cel and glofitamab as combination therapy on the best complete response rate in 2nd line LBCL participants Secondary Objectives * To evaluate the effect of axi-cel and glofitamab as combination therapy on overall survival (OS) in 2nd line LBCL participants * To evaluate the effect of axi-cel and glofitamab as combination therapy on progression free survival in 2nd line LBCL participants * To evaluate the effect o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically proven CD19- and CD20-positive LBCL, including transformation from indolent lymphomas. * Have disease that is refractory to or relapsed \<=12 months after the completion of first-line chemoimmunotherapy • Refractory disease defined as no complete response (CR) to first-line therapy; participants who are intolerant to first-line therapy are excluded * Progressive disease (PD) as best response to first-line therapy * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) * Partial response (PR) as bes…
Interventions
- DrugGlofitamab
Given by IV
- DrugObinutuzumab
Given by IV
- DrugAxi-cel
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas