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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104478
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

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

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Study Type : Observational
Estimated Enrollment : 194 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma


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.


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.


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

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


Contacts
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Contact: Christine Stephan 04 72 66 93 33 christine.stephan@lysarc.org

Locations
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France
CHU Caen Recruiting
Caen, France, 14000
Contact: Gandhi Laurent DAMAJ       damaj-gl@chu-caen.fr   
Principal Investigator: Gandhi Laurent DAMAJ, Doctor         
Hopital Henri Mondor Recruiting
Creteil, France, 94010
Contact: Corinne HAIOUN       corinne.haioun@hmn.aphp.fr   
Principal Investigator: Corinne HAIOUN, Professor         
CHU Le Bocage Recruiting
Dijon, France, 21034
Contact: Olivier CASASNOVAS       olivier.casasnovas@chu-dijon.fr   
Principal Investigator: Olivier CASASNOVAS, Doctor         
CH Départemental Recruiting
La Roche sur Yon, France, 85925
Contact: Hervé MAISONNEUVE       herve.maisonneuve@chd-vendee.fr   
Principal Investigator: Hervé MAISONNEUVE, Doctor         
CHU Claude Hurriez Recruiting
Lille, France, 59037
Contact: Franck MORSCHHAUSER       franck.morschhauser@chru-lille.fr   
Principal Investigator: Franck MORSCHHAUSER, Doctor         
CHU Montpellier Recruiting
MONTPELLIER Cedex 5, France, 34295
Contact: Guillaume CARTRON       g-cartron@chu-montpellier.fr   
Principal Investigator: Guillaume CARTRON, Professor         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Steven LE GOUILL       steven.legouill@chu-nantes.fr   
Principal Investigator: Steven LE GOUILL, Porfessor         
Centre Francois Magendie Recruiting
Pessac, France, 33604
Contact: Krimo BOUABDALLAH       krimo.bouabdallah@chu-bordeaux.fr   
Principal Investigator: Krimo BOUABDALLAH, Doctor         
CHU Lyon Sud Recruiting
Pierre Bénite cedex, France, 69495
Contact: Gilles SALLES       gilles.salles@chu-lyon.fr   
Principal Investigator: Gilles SALLES, Professor         
CHU de Poitiers - Hôpital de la Miletrie Recruiting
Poitiers, France, 86021
Contact: Vincent DELWAIL       vincent.delwail@chu-poitiers.fr   
Principal Investigator: Vincent DELWAIL, Doctor         
Ch Annecy Genevois Recruiting
Pringy, France, 74370
Contact: Nicolas DAGUINDAU       ndaguindau@ch-annecygenevois.fr   
Principal Investigator: Nicolas DAGUINDAU, Doctor         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Fabrice JARDIN       fabrice.jardin@chb.unicancer.fr   
Principal Investigator: Fabrice JARDIN, Professor         
IUCT Oncopôle - CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Lucie OBERIC       oberic.l@chu-toulouse.fr   
Principal Investigator: Lucie OBERIC, Doctor         
CHU Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: PIERRE FEUGIER       p.feugier@chu-nancy.fr   
Principal Investigator: Pierre FEUGIER, Professor         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Vincent RIBRAG       vincent.ribrag@gustaveroussy.fr   
Principal Investigator: Vincent RIBRAG, doctor         
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
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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: March 13, 2020
Last Verified: March 2020
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