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

NCT ID: NCT03104478

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-09

Study Completion Date

2021-09-04

Brief Summary

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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.

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Keywords

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DLBCL Real time molecular characterization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lymphoma Academic Research Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Jardin, Pr

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Christiane Copie, Pr

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

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CHU Caen

Caen, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

CHU Le Bocage

Dijon, , France

Site Status

CH Départemental

La Roche-sur-Yon, , France

Site Status

CHU Claude Hurriez

Lille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Centre Francois Magendie

Pessac, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

CHU de Poitiers - Hôpital de la Miletrie

Poitiers, , France

Site Status

Ch Annecy Genevois

Pringy, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

IUCT Oncopôle - CHU de Toulouse

Toulouse, , France

Site Status

CHU Nancy Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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RT3

Identifier Type: -

Identifier Source: org_study_id