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

Completed

• Conditions: Diffuse Large B Cell Lymphoma

• Registration Number: NCT03104478
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Study Start: 2017-05-09
• Primary Completion: 2019-10-11
• Study Completion: 2021-09-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real time report of molecular characterization	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

Trial Locations

Locations (15)

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

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