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OpenTrials
Completed

NCT Number: NCT05338879

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Facility, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Treatment and study plan

Non-Interventional

Other

No study treatment will be administered on this study.

Primary outcomes

  1. Objective response rate

    Time frame: Up to 84 months

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

Secondary outcomes

  1. Complete Response (CR) rate

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)].

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: FLORA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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