Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma (FLORA)

Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)

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)

Study Overview

• Status: Completed
• Conditions: Relapsed/Refractory Follicular Lymphoma
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 38 8036
    • Regeneron Research Facility
• France
  • Caen, France, 14033
    • Regeneron Research Facility
  • Paris, France, 75010
    • Regeneron Research Facility
  • Pierre-Benite, France, 69310
    • Regeneron Research Facility
• Germany
  • Essen, Germany, 45147
    • Regeneron Research Facility
  • Frankfurt, Germany, 60590
    • Regeneron Research Facility
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Regeneron Research Facility
  • Manchester, United Kingdom, M20 4BX
    • Regeneron Research Facility
  • Nottingham, United Kingdom, NG5 1PB
    • Regeneron Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with FL grade1-3a who have relapsed after or are refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

Description

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 Exclusion Criteria:

1. Evidence of histological transformation (HT) prior to index date (ie, evolution to a clinically aggressive non-hodgkin's lymphoma (NHL) such as diffuse large B-Cell lymphoma (DLBCL) as defined in the protocol
2. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
3. History of allo-stem cell transplant (SCT) prior to index date
4. Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
5. Another malignancy in the 5 years on or prior to index date, with the exception of non-melanoma skin cancer and B-NHL
6. History of neurodegenerative condition or CNS movement disorder on or prior to index date
7. Evidence of significant cardiovascular disease on or prior to index date
8. Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date.
9. Eastern Cooperative Oncology Group (ECOG) performance status >1 on or prior to index date.
10. Inadequate organ function as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Participants with r/r FL grade 1-3a who were treated with at least 2 prior systemic therapies in the real-world setting.	Other: Non-Interventional; No study treatment will be administered on this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The proportion of best overall response of complete response (CR) or partial response (PR).	Up to 84 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) rate	The proportion of patients with a CR after initiation of the selected line of therapy (LoT).	Up to 84 months
Progression Free Survival (PFS)	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.	Up to 84 months
Overall Survival (OS)	The time from the start date of the selected LoT until death due to any cause.	Up to 84 months
Duration of Response (DOR)	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.	Up to 84 months
Disease Control Rate (DCR)	The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD).	Up to 84 months
Time to Next Treatment (TTNT)	The time from the start date of the selected LoT to the start of a new antineoplastic treatment line.	Up to 84 months
Histological transformation (HT)	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)].	Up to 84 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diffuse large B-cell lymphoma; B-cell non-Hodgkin lymphoma; Odronextamab; FLORA
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular
• Other Study ID Numbers: R1979-ONC-20103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No