Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT ID: NCT05338892

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 595 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-10-05

Brief Summary

Primary Objective:

To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:

1. ORR according to Lugano classification and as assessed by treating physician evaluation

2. Complete Response (CR) rate according to Lugano classification and as assessed by:

• Independent central review, and
• Treating physician evaluation

3. Progression Free Survival (PFS) according to Lugano classification and as assessed by:

• Independent central review, and
• Treating physician evaluation

4. Overall Survival (OS)

5. Duration of response (DOR) according to Lugano classification and as assessed by

• Independent central review and
• Treating physician evaluation

6. Disease control rate (DCR) according to Lugano classification and as assessed by:

• Independent central reviewed
• Treating physician evaluation

7. Time to next treatment (TTNT)

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1

Participants with r/r DLBCL 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

Non-Interventional

No study treatment will be administered on this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Have a histologically confirmed diagnosis of DLBCL on or after 01 Jan 2010 as defined in the protocol

2. Have been r/r to at least 2 lines of systemic therapy for DLBCL, 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 been seen at a site that routinely assesses DLBCL treatment response according to Lugano classification of malignant lymphoma (ie, sites with ≥50% DLBCL patients with treatment response according to Lugano classification)

6. Have DLBCL treatment response assessed according to Lugano classification of malignant lymphoma or are deceased prior to opportunity for assessment

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS non-Hodgkin's lymphoma (NHL) on or prior to index date

2. History of allo-stem cell transplant (SCT) prior to index date

3. Treatment with any chimeric antigen receptor T (CAR-T) therapy prior to index date

4. Received anti-CD20 x anti-CD3 bispecific therapy prior to index date

5. History of neurodegenerative condition or CNS movement disorder on or prior to index date

6. Evidence of significant cardiovascular disease on or prior to index date

7. Evidence of significant pulmonary disease, defined as obstructive pulmonary disease and a history of symptomatic bronchospasm on or prior to index date

8. Eastern Cooperative Oncology Group (ECOG) performance status >1 on or prior to index date

9. Inadequate organ function as defined in the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Research Facility

Graz, , Austria

Regeneron Research Facility

Caen, , France

Regeneron Research Facility

Paris, , France

Regeneron Research Facility

Pierre-Bénite, , France

Regeneron Research Facility

Essen, , Germany

Regeneron Research Facility

Frankfurt, , Germany

Regeneron Research Facility

London, , United Kingdom

Regeneron Research Facility

Manchester, , United Kingdom

Regeneron Research Facility

Nottingham, , United Kingdom

Countries

Austria; France; Germany; United Kingdom

Other Identifiers

R1979-ONC-2090

Identifier Type: -

Identifier Source: org_study_id