Refractory Diffuse Large B-cell Lymphoma

Completed

• Conditions: Diffuse Large B-cell Lymphoma

• Registration Number: NCT03664336
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2017-07
• Study Completion: 2018-01
• Study First Submitted: 2018-08-22
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

-≥18 years of age

• diagnosed with DLBCL at Lyon Sud University Hospital (LSUH) from January 2002 to January 2017
• presented with refractory disease in response to front-line therapies
• including anthracycline-based chemo and a monoclonal anti-CD20 antibody

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Exclusion Criteria

• Patients with a history of indolent lymphoma,
• Patients with a primary central nervous system (CNS) lymphoma or immunosuppression-related lymphoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome according to pattern of refractoriness	Up to 4 years	OS was defined as the time from first relapse, or progression, to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Outcome according to pattern of refractoriness	Up tp 24 months	EFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause). Patients who did not experience an event were censored at the last follow-up.

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France