Diffuse Large B-Cell Lymphoma
Conditions
Keywords
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL), Non-Hodgkin lymphoma, Chronic lymphocytic leukemia, Follicular lymphoma, Odronextamab, ORCHID
Brief 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)
Interventions
OTHERNon-Interventional
No study treatment will be administered on this study.
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol 2. Have been r/r to at least 2 lines of systemic therapy for DLBCL, including an anti-CD20 antibody and an alkylating agent as defined in the protocol 3. Have initiated at least one additional line (3L+) of systemic therapy (salvage therapy) for DLBCL between 01 Jan 2015 and 30 Jun 2021 (indexing period) after meeting the criteria for r/r DLBCL as described above; the first additional line of systemic therapy during the indexing period that meets all of the remaining inclusion and
Exclusion criteria
defined below will be the patients' first qualifying salvage therapy. 4. Have measurable disease on cross sectional imaging (defined as at least 1 bi-dimensionally measurable nodal lesion ≥1.5 centimeter \[cm\] in the greatest transverse diameter \[GTD\] regardless of the short axis diameter) documented by diagnostic imaging (computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) recorded on or during the 8 weeks prior to index date 5. Have been seen at a site that routinely assesses DLBCL treatment response according to Lugano classification of malignant lymphoma (ie, sites with ≥50% DLBCL patients with treatment response according to Lugano classification) 6. Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 84 months | The proportion of best overall response of complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 84 months | The time from the start date of the selected LoT until the first date of progressive disease (PD) or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 84 months | The time from the start date of the selected LoT until death due to any cause. |
| Complete Response (CR) rate | Up to 84 months | The proportion of patients with a CR after initiation of the selected line of therapy (LoT). |
| Disease Control Rate (DCR) | Up to 84 months | The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD). |
| Time to Next Treatment (TTNT) | Up to 84 months | The time from the start date of the selected LoT to the start of a new antineoplastic treatment line. |
| Duration of Response (DOR) | Up to 84 months | The time from the date of the first documented CR or PR until the first date of PD or death due to any cause, whichever occurs first. |
Countries
Austria, France, Germany, United Kingdom
Outcome results
None listed