NCT05338892

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 595 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting: 1. ORR according to Lugano classification and as assessed by treating physician evaluation 2. Complete Response (CR) rate according to Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 3. Progression Free Survival (PFS) according to Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 4. Overall Survival (OS) 5. Duration of response (DOR) according to Lugano classification and as assessed by * Independent central review and * Treating physician evaluation 6. Disease control rate (DCR) according to Lugano classification and as assessed by: * Independent central reviewed * Treating physician evaluation 7. Time to next treatment (TTNT)

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
OTHER	Non-Interventional	No study treatment will be administered on this study.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2022-04-21
• Last updated: 2023-10-19

Locations

9 sites across 4 countries: Austria, France, Germany, United Kingdom