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

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen, Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological samples collection

Procedure

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 outcomes

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

Sponsors and collaborators

Lead sponsor

The Lymphoma Academic Research Organisation

Other

Registry information

Acronym: RT3

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2021
First posted: Apr 7, 2017
Registry last updated: Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed