Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
RT3
1 other identifier
observational
219
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2021
CompletedDecember 7, 2021
December 1, 2021
2.4 years
April 3, 2017
December 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
Patient ≥ 18 years old with prior untreated DLBCL
You may qualify if:
- 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
- Patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations
You may not qualify if:
- No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite
- No signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
CHU Caen
Caen, 14000, France
Hopital Henri Mondor
Créteil, 94010, France
CHU Le Bocage
Dijon, 21034, France
CH Départemental
La Roche-sur-Yon, 85925, France
CHU Claude Hurriez
Lille, 59037, France
CHU Montpellier
Montpellier, 34295, France
CHU de Nantes
Nantes, 44093, France
Centre Francois Magendie
Pessac, 33604, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers - Hôpital de la Miletrie
Poitiers, 86021, France
Ch Annecy Genevois
Pringy, 74370, France
Centre Henri Becquerel
Rouen, 76038, France
IUCT Oncopôle - CHU de Toulouse
Toulouse, 31059, France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy
Villejuif, 94805, France
Biospecimen
Blood samples are collected at time of enrollment in the trial.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Jardin, Pr
Lymphoma Study Association
- PRINCIPAL INVESTIGATOR
Christiane Copie, Pr
Lymphoma Study Association
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
May 9, 2017
Primary Completion
October 11, 2019
Study Completion
September 4, 2021
Last Updated
December 7, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share