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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05338879
• Collaborator: (none)
• Enrollment: 450
• Locations: 6
• Anticipated Duration (Months): 8.3
• Patients Per Site: 75
• Patients Per Site Per Month: 9

Study Details

Study Description

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

1. Progression-free survival (PFS) according to the Lugano classification and as assessed by:

• Independent central review, and

• Treating physician evaluation

1. Overall survival (OS)

2. Duration of response (DOR) according to the Lugano classification and as assessed by:

• Independent central review, and

• Treating physician evaluation

1. Disease control rate (DCR) according to the Lugano classification and as assessed by:

• Independent central review, and

• Treating physician evaluation

1. Time to next treatment (TTNT)

2. Histological transformation (HT)

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Follicular Lymphoma	Other: Non-Interventional

Study Design

• Study Type: Observational
• Anticipated Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)
• Actual Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Feb 24, 2023
• Anticipated Study Completion Date: Feb 24, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Objective response rate [Up to 84 months]

   The proportion of best overall response of complete response (CR) or partial response (PR).

Secondary Outcome Measures

1. Complete Response (CR) rate [Up to 84 months]

   The proportion of patients with a CR after initiation of the selected line of therapy (LoT).

2. 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.

3. Overall Survival (OS) [Up to 84 months]

   The time from the start date of the selected LoT until death due to any cause.

4. 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.

5. 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).

6. 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.

7. 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)].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Research Facility	Caen		France	14033
2	Regeneron Research Facility	Paris		France	75010
3	Regeneron Research Facility	Pierre-Benite		France	69310
4	Regeneron Research Facility	Frankfurt		Germany	60590
5	Regeneron Research Facility	London		United Kingdom	EC1A 7BE
6	Regeneron Research Facility	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05338879
• Other Study ID Numbers: R1979-ONC-20103
• First Posted: Apr 21, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Regeneron Pharmaceuticals: B-cell non-Hodgkin lymphoma; Diffuse large B-cell lymphoma; Odronextamab; FLORA
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular

Study Results

No Results Posted as of Aug 9, 2022