Clinical trial NCT03104478: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
Official title: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Keywords: DLBCL
Real time molecular characterization
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient ≥ 18 years old with prior untreated DLBCL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Real time report of molecular characterization
timeFrame: 38 days (i.e. 38 days after starting inductive chemotherapy regimen
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU Le Bocage
city: La Roche sur Yon
country: France
facility: CH Départemental
city: Lille
country: France
facility: CHU Claude Hurriez
city: MONTPELLIER Cedex 5
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Pessac
country: France
facility: Centre Francois Magendie
city: Pierre Bénite cedex
country: France
facility: CHU Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Miletrie
city: Pringy
country: France
facility: Ch Annecy Genevois
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: IUCT Oncopôle - CHU de Toulouse
city: Vandoeuvre Les Nancy
country: France
facility: CHU Nancy Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Lymphoma Study Association
name: Fabrice Jardin, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Lymphoma Study Association
name: Christiane Copie, Pr
role: PRINCIPAL_INVESTIGATOR
References: