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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

247 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-22

Study Completion Date

2023-10-05

Brief Summary

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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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Detailed Description

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Conditions

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Relapsed/Refractory Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Non-Interventional

Intervention Type OTHER

No study treatment will be administered on this study.

Interventions

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Non-Interventional

No study treatment will be administered on this study.

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No