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

Relapsed/Refractory Follicular Lymphoma Clinical Trial

— FLORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338879
• Other study ID #: R1979-ONC-20103
• Status: Completed
• Start date: June 22, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Relapsed/Refractory Follicular Lymphoma

Intervention

Other:
• Non-Interventional
No study treatment will be administered on this study.

Locations

Country	Name	City	State
Austria	Regeneron Research Facility	Graz
France	Regeneron Research Facility	Caen
France	Regeneron Research Facility	Paris
France	Regeneron Research Facility	Pierre-Benite
Germany	Regeneron Research Facility	Essen
Germany	Regeneron Research Facility	Frankfurt
United Kingdom	Regeneron Research Facility	London
United Kingdom	Regeneron Research Facility	Manchester
United Kingdom	Regeneron Research Facility	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Austria,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The proportion of best overall response of complete response (CR) or partial response (PR).	Up to 84 months
Secondary	Complete Response (CR) rate	The proportion of patients with a CR after initiation of the selected line of therapy (LoT).	Up to 84 months
Secondary	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
Secondary	Overall Survival (OS)	The time from the start date of the selected LoT until death due to any cause.	Up to 84 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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