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

December 6, 2021 updated by: The Lymphoma Academic Research Organisation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

219

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
      • Caen, France, 14000
        • CHU Caen
      • Creteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon, France, 21034
        • CHU Le Bocage
      • La Roche sur Yon, France, 85925
        • CH Départemental
      • Lille, France, 59037
        • CHU Claude Hurriez
      • MONTPELLIER Cedex 5, France, 34295
        • CHU Montpellier
      • Nantes, France, 44093
        • CHU de Nantes
      • Pessac, France, 33604
        • Centre Francois Magendie
      • Pierre Bénite cedex, France, 69495
        • CHU Lyon Sud
      • Poitiers, France, 86021
        • CHU de Poitiers - Hôpital de la Milétrie
      • Pringy, France, 74370
        • CH Annecy Genevois
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 31059
        • IUCT Oncopôle - CHU de Toulouse
      • Vandoeuvre Les Nancy, France, 54511
        • CHU Nancy Brabois
      • Villejuif, France, 94805
        • Institut Gustave Roussy

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient ≥ 18 years old with prior untreated DLBCL

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
38 days (i.e. 38 days after starting inductive chemotherapy regimen

Collaborators and Investigators

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

Sponsor

The Lymphoma Academic Research Organisation

Investigators

  • Principal Investigator: Fabrice Jardin, Pr, Lymphoma Study Association
  • Principal Investigator: Christiane Copie, Pr, Lymphoma Study Association

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)

May 9, 2017

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

September 4, 2021

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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