Refractory Diffuse Large B-cell Lymphoma

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664336
• Other study ID #: refractory DLBCL
• Status: Completed
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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