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

Diffuse Large B Cell Lymphoma Clinical Trial

— RT3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104478
• Other study ID #: RT3
• Status: Completed
• Start date: May 9, 2017
• Est. completion date: September 4, 2021

Study information

• Verified date: December 2021
• Source: The Lymphoma Academic Research Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: September 4, 2021
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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.

Locations

Country	Name	City	State
France	CHU Caen	Caen
France	Hopital Henri Mondor	Creteil
France	CHU Le Bocage	Dijon
France	CH Départemental	La Roche sur Yon
France	CHU Claude Hurriez	Lille
France	CHU Montpellier	MONTPELLIER Cedex 5
France	CHU de Nantes	Nantes
France	Centre Francois Magendie	Pessac
France	CHU Lyon Sud	Pierre Bénite cedex
France	CHU de Poitiers - Hôpital de la Miletrie	Poitiers
France	Ch Annecy Genevois	Pringy
France	Centre Henri Becquerel	Rouen
France	IUCT Oncopôle - CHU de Toulouse	Toulouse
France	CHU Nancy Brabois	Vandoeuvre Les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
The Lymphoma Academic Research Organisation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real time report of molecular characterization	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