Relapsed/Refractory Follicular Lymphoma
Conditions
Keywords
B-cell non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Odronextamab, FLORA
Brief summary
Primary Objective: To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review. Secondary Objectives: To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting: 1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation 2. Complete response (CR) rate according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 3. Progression-free survival (PFS) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 4. Overall survival (OS) 5. Duration of response (DOR) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 6. Disease control rate (DCR) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 7. Time to next treatment (TTNT) 8. Histological transformation (HT)
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 FL grade1-3a as defined in the protocol 2. Have been r/r to at least 2 lines of systemic therapy for FL grade 1-3a, including an anti-CD20 antibody and an alkylating agent as defined in the protocol 3. Have initiated at least one additional line of systemic therapy (salvage therapy) for FL grade 1-3a between 01 Jan 2015 and 31 Dec 2020 (indexing period) after meeting the criteria for r/r FL grade 1-3a 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 participants' 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 FL 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. |
| 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. |
| Complete Response (CR) rate | Up to 84 months | The proportion of patients with a CR after initiation of the selected line of therapy (LoT). |
| 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. |
| Histological transformation (HT) | Up to 84 months | The proportion of patients with evidence of HT \[ie, evolution to a clinically aggressive non-Hodgkin lymphoma such as Diffuse large B-cell lymphoma (DLBCL)\]. |
| 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). |
Countries
Austria, France, Germany, United Kingdom
Outcome results
None listed