Relapsed/Refractory Follicular LymphomaFLORANCT05338879
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma
An observational study of Relapsed/Refractory Follicular Lymphoma, run by Regeneron Pharmaceuticals at 9 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Follicular Lymphoma
- What is being tested?
- Non-Interventional
- How many people
- 247 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 22 Jun 2022to 5 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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
- 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
Who cannot join
- 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
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- 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
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France3 sites
Regeneron Research Facility
Caen, 14033
Regeneron Research Facility
Paris, 75010
Regeneron Research Facility
Pierre-Bénite, 69310
United Kingdom3 sites
Regeneron Research Facility
London, EC1A 7BE
Regeneron Research Facility
Manchester, M20 4BX
Regeneron Research Facility
Nottingham, NG5 1PB
Germany2 sites
Regeneron Research Facility
Essen, 45147
Regeneron Research Facility
Frankfurt, 60590
About this study
Official title: 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.
Read more
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:
- Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation
- Complete response (CR) rate according to the Lugano classification and as assessed by:
- 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)
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Being tested
- Non-Interventional
- Keywords
- B-cell non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Odronextamab, FLORA
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
No study treatment will be administered on this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of best overall response of complete response (CR) or partial response (PR).
Measured: Up to 84 months
Secondary outcomes (7)
Complete Response (CR) rate
The proportion of patients with a CR after initiation of the selected line of therapy (LoT).
Measured: 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.
Measured: Up to 84 months
Overall Survival (OS)
The time from the start date of the selected LoT until death due to any cause.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)].
Measured: Up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start22 Jun 2022
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338879
- Sponsor's protocol ID
- R1979-ONC-20103
- Acronym
- FLORA
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)
- ClinicalTrials.gov ID
- NCT05338879
- Acronym / sponsor ID
- FLORA / R1979-ONC-20103
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Keywords
- B-cell non-Hodgkin lymphoma, Diffuse large B-cell lymphoma, Odronextamab, FLORA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation
- Complete response (CR) rate according to the Lugano classification and as assessed by:
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Non-InterventionalParticipants with r/r FL grade 1-3a who were treated with at least 2 prior systemic therapies in the real-world setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNo study treatment will be administered on this study. | Other | Cohort 1 |
Primary outcome
Objective response rate
Time frame: Up to 84 months
The proportion of best overall response of complete response (CR) or partial response (PR).
7 secondary outcomes
Complete Response (CR) rate
Time frame: Up to 84 months
Progression Free Survival (PFS)
Time frame: Up to 84 months
Overall Survival (OS)
Time frame: Up to 84 months
Duration of Response (DOR)
Time frame: Up to 84 months
Disease Control Rate (DCR)
Time frame: Up to 84 months
Time to Next Treatment (TTNT)
Time frame: Up to 84 months
Histological transformation (HT)
Time frame: Up to 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Follicular Lymphoma, run by Regeneron Pharmaceuticals at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, United Kingdom, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Up to 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.