Real world study on Relapse/Refractory Diffuse Large B-Cell Lymphoma
Research type
Research Study
Full title
Outcomes in Patients with Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated with Systemic Therapy from Real-World Experience (ORCHID)
IRAS ID
312469
Contact name
John Gribben
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Duration of Study in the UK
1 years, 0 months, 25 days
Research summary
This is an observational study designed to provide contextualization to the R1979-ONC-1625 single-arm clinical trial. Treatment outcomes from patients with r/r diffuse large B-cell lymphoma (DLBCL) who received odronextamab monotherapy in the clinical trial study will be contextualised using retrospective data from patients who received the standard of care in a real-world setting.
The primary study objective is to evaluate objective response rate (ORR) in adult patients with Diffuse large B-cell lymphoma (DLBCL) who receive systemic treatment after at least two prior systemic therapies in the real-world setting according to the Lugano classification of malignant lymphoma and as assessed by independent central review. The secondary objectives are to evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available systemic therapies in the real-world setting: ORR, complete response (CR) rate, progression-free survival (PFS), OS, duration of response (DOR), disease control rate (DCR) and time to next treatment (TTNT).
The primary endpoint of the study is ORR in the real-world setting, defined as the proportion of best overall response of CR or partial response (PR). ORR will be defined according to the Lugano classification of malignant lymphoma as assessed by independent central review. The secondary endpoints of the study are as follows and will be defined relative to the selected line of therapy (LoT): ORR, CR rate, PFS, OS, DOR, DCR, TTNT.
Data will be collected retrospectively from a combination of electronic medical record (EMR) or research database extraction of structured data and manual abstraction of unstructured data. The data collection will cover patients who initiated qualifying 3L+ treatments in the period from 2015 to 2021 with treatment histories as early as 2010. Data will be collected from multiple oncology centers in Asia, Europe, and North America. Countries participating in this study may change based on feasibility.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0094
Date of REC Opinion
13 Apr 2022
REC opinion
Further Information Favourable Opinion