Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Refractory Diffuse Large B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664336
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Diffuse Large B-cell Lymphoma

Layout table for study information
Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Outcome according to pattern of refractoriness [ Time Frame: Up to 4 years ]
    OS was defined as the time from first relapse, or progression, to death from any cause.


Secondary Outcome Measures :
  1. Outcome according to pattern of refractoriness [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Man or woman diagnosed for a DLBCL from January 2002 to January 2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664336


Locations
Layout table for location information
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Clémentine Sarkozy, MD Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03664336     History of Changes
Other Study ID Numbers: refractory DLBCL
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
diffuse large B-cell lymphoma
refractory
rituximab

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin