Refractory Diffuse Large B-cell Lymphoma | NCT03664336

Studies
Refractory Diffuse Large B-cell Lymphoma

NCT03664336

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Sep 10, 2018Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Aug 22, 2018

First Submission Date that Met QC Criteria

Sep 7, 2018

First Posted Date

Sep 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2018

Last Update Posted Date

Sep 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clémentine Sarkozy, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Lyon Sud		Pierre-Bénite			France

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided