Non-Interventional
OtherNo study treatment will be administered on this study.
NCT Number: NCT05338879
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)
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Notify Me18 year and older
All sexes
Observational
Regeneron Research Facility, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
No study treatment will be administered on this study.
Time frame: Up to 84 months
The proportion of best overall response of complete response (CR) or partial response (PR).
Time frame: Up to 84 months
The proportion of patients with a CR after initiation of the selected line of therapy (LoT).
Time frame: 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.
Time frame: Up to 84 months
The time from the start date of the selected LoT until death due to any cause.
Time frame: 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.
Time frame: Up to 84 months
The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD).
Time frame: Up to 84 months
The time from the start date of the selected LoT to the start of a new antineoplastic treatment line.
Time frame: 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)].
Regeneron Pharmaceuticals
Industry
Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)
Acronym: FLORA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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