Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

September 7, 2018 updated by: Hospices Civils de Lyon

Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.

Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

95 consecutive patients who fulfilled the eligibility criteria for this study were reviewed retrospectively with data cut-off of December 2014. FL patients in relapse after ASCT. All patients presented at diagnosis a grade 1, 2, or 3A follicular lymphoma confirmed by either excisional or core needle biopsy.

Description

Inclusion Criteria:

  • they were older than 18 years
  • presented FL at diagnosis (Grade 1, 2, or 3a).
  • received high-dose therapy (HDT) with ASCT from 2000 to 2014

Exclusion Criteria:

  1. they had already been treated with a 1st ASCT,
  2. had a previous history of histological transformation before ASCT
  3. if they were rituximab naive prior to ASCT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival after relapse (SAR) post ASCT in follicular lymphoma
Time Frame: Year 6
Factors that predicted SAR
Year 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological Transformation at relapse
Time Frame: Year 6
A biopsy was performed at the first relapse or progression after ASCT.
Year 6
treatment of relapse
Time Frame: Year 6
Chemotherapy, radiotherapy…
Year 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Director: Pierre SESQUES, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

July 31, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCT Sesques

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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