NCT05338879

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:

  • Independent central review, and
  • Treating physician evaluation
  • Progression-free survival (PFS) according to the Lugano classification and as assessed by:
  • Independent central review, and
  • Treating physician evaluation
  • Overall survival (OS)
  • Duration of response (DOR) according to the Lugano classification and as assessed by:
  • Independent central review, and
  • Treating physician evaluation
  • Disease control rate (DCR) according to the Lugano classification and as assessed by:
  • Independent central review, and
  • Treating physician evaluation
  • Time to next treatment (TTNT)
  • Histological transformation (HT)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 22, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 14, 2022

Last Update Submit

October 17, 2023

Conditions

Relapsed/Refractory Follicular Lymphoma

Keywords

B-cell non-Hodgkin lymphomaDiffuse large B-cell lymphomaOdronextamabFLORA

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

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

    Up to 84 months

Secondary Outcomes (7)

  • Complete Response (CR) rate

    Up to 84 months

  • Progression Free Survival (PFS)

    Up to 84 months

  • Overall Survival (OS)

    Up to 84 months

  • Duration of Response (DOR)

    Up to 84 months

  • Disease Control Rate (DCR)

    Up to 84 months

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

Non-InterventionalOTHER

No study treatment will be administered on this study.

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Have a histologically confirmed diagnosis of FL grade1-3a as defined in the protocol
  • 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

You may not qualify if:

  • 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
  • Have FL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment
  • 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
  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date
  • History of allo-stem cell transplant (SCT) prior to index date
  • Received anti-CD20 x anti-CD3 bispecific therapy prior to index date
  • Another malignancy in the 5 years on or prior to index date, with the exception of non-melanoma skin cancer and B-NHL
  • History of neurodegenerative condition or CNS movement disorder on or prior to index date
  • Evidence of significant cardiovascular disease on or prior to index date
  • Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date.
  • Eastern Cooperative Oncology Group (ECOG) performance status \>1 on or prior to index date.
  • Inadequate organ function as defined in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Regeneron Research Facility

Graz, 38 8036, Austria

Location

Regeneron Research Facility

Caen, 14033, France

Location

Regeneron Research Facility

Paris, 75010, France

Location

Regeneron Research Facility

Pierre-Bénite, 69310, France

Location

Regeneron Research Facility

Essen, 45147, Germany

Location

Regeneron Research Facility

Frankfurt, 60590, Germany

Location

Regeneron Research Facility

London, EC1A 7BE, United Kingdom

Location

Regeneron Research Facility

Manchester, M20 4BX, United Kingdom

Location

Regeneron Research Facility

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, B-CellLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

June 22, 2022

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)FR(3)AU(1)GB(3)