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

The Lymphoma Academic Research Organisation

Status: Completed

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Procedure: Biological samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT03104478

RT3

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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