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Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL) (RT3)

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: NCT03104478
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Study Description
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Brief Summary:

The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients.

The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.


Condition or disease Intervention/treatment
Diffuse Large B Cell Lymphoma Procedure: Biological samples collection

Study Design
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Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : September 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Procedure: Biological samples collection
    In addition to collection and characterization of tumor biopsy samples done for diagnosis (standard care), collection of blood samples at study entry for further biological analyses.

Outcome Measures
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Primary Outcome Measures :
  1. Real time report of molecular characterization [ Time Frame: 38 days (i.e. 38 days after starting inductive chemotherapy regimen ]
    To timely report the molecular characterization (pathogenic, diagnostic, prognostic, theranostic markers) of previously untreated DLBCL patients prior to day 38(i.e. 38 days after starting inductive chemotherapy regimen, in at least 80% of enrolled patients


Biospecimen Retention:   Samples With DNA
Blood samples are collected at time of enrollment in the trial.

Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient ≥ 18 years old with prior untreated DLBCL
Criteria

Inclusion Criteria:

  • DLBCL patients that will be eligible in front-line treatment for a combination of anthracycline-based chemotherapy plus anti-CD20 monoclonal antibody,Rituximab: R-CHOP 14, R-CHOP 21, R mini-CHOP, R-ACVBP, R-COPADEM. Patients treated with R-CHOP associated with an experimental drug ((polatuzumab, tazemetostat, venetoclax, entospletinib, lenalidomide, ibrutinib, anti PD1/anti PDL1 ….)
  • A short corticotherapy (prednisone, maximum 7 days) given during pre-phase therapy is allowed.
  • Eligible histological subtypes: in particular DLBCL NOS, PMBL, high grade B-cell lymphoma (HGBCL) withMYC and BCL2 and/or BCL6 rearrangements, HGBCL NOSFL grade 3B and untreated transformed low grade NHL.
  • ≥ 18 years old, IPI = 0-5
  • With available tumor Biopsy (FFPE) that can be sent to RT3 platform at the time of inclusion (or the say after inclusion at the latest).
  • Patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations

Exclusion Criteria:

  • No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite
  • No signed informed consent
Contacts and Locations
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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): NCT03104478


Locations
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France
CHU Caen
Caen, France, 14000
Hopital Henri Mondor
Creteil, France, 94010
CHU Le Bocage
Dijon, France, 21034
CH Départemental
La Roche sur Yon, France, 85925
CHU Claude Hurriez
Lille, France, 59037
CHU Montpellier
MONTPELLIER Cedex 5, France, 34295
CHU de Nantes
Nantes, France, 44093
Centre Francois Magendie
Pessac, France, 33604
CHU Lyon Sud
Pierre Bénite cedex, France, 69495
CHU de Poitiers - Hôpital de la Miletrie
Poitiers, France, 86021
Ch Annecy Genevois
Pringy, France, 74370
Centre Henri Becquerel
Rouen, France, 76038
IUCT Oncopôle - CHU de Toulouse
Toulouse, France, 31059
CHU Nancy Brabois
Vandoeuvre Les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
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Principal Investigator: Fabrice Jardin, Pr Lymphoma Study Association
Principal Investigator: Christiane Copie, Pr Lymphoma Study Association
More Information
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT03104478    
Other Study ID Numbers: RT3
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 The Lymphoma Academic Research Organisation:
DLBCL
Real time molecular characterization
Additional relevant MeSH terms:
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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