A Real World Study of Treatment of Relmacabtagene Autoleucel in Relapsed or Refractory Large B-Cell Lymphoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
Brief Summary
To evaluate the efficacy and safety of Relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) in real-world
Detailed Description
This is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. The purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r LBCL with Relmacabtagene autoleucel. The treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.There will be no therapeutic intervention as a result of this study. There will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with established r/r LBCL;
- •Patients already treated with commercially available Relmacabtagene Autoleucel
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ORR
Time Frame: 6 months
Percentage of participants with CR or PR
Secondary Outcomes
- CRR(6 months)
- DOR(6 months)
- Overall Survival (OS)(6 months)
- Progression-Free Survival (PFS)(6 months)
- Adverse events (AEs)(6 months)