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

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: NCT03663894
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:

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.


Condition or disease
Patient's Outcome Prognostic Factors

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era
Actual Study Start Date : July 30, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Survival after relapse (SAR) post ASCT in follicular lymphoma [ Time Frame: Year 6 ]
    Factors that predicted SAR


Secondary Outcome Measures :
  1. Histological Transformation at relapse [ Time Frame: Year 6 ]
    A biopsy was performed at the first relapse or progression after ASCT.

  2. treatment of relapse [ Time Frame: Year 6 ]
    Chemotherapy, radiotherapy…



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

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): NCT03663894


Locations
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France
Centre Hospitalier Lyon Sud, Hematology department
Pierre-Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Pierre SESQUES, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03663894    
Other Study ID Numbers: ASCT Sesques
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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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:
Autologous stem cell transplantation
rituximab
Follicular Lymphoma
prognosis
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin