Refractory Diffuse Large B-cell Lymphoma

Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Man or woman diagnosed for a DLBCL from January 2002 to January 2017

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome according to pattern of refractoriness	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.	Up tp 24 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Clémentine Sarkozy, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: rituximab; refractory; diffuse large B-cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: refractory DLBCL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No