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Diffuse Large B Cell LymphomaRT3NCT03104478

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

An observational study of Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Biological samples collection
Type of treatment
Surgery or procedure
How many people
219 participants
Where
15 sitesFrance
Study dates
9 May 2017to 4 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient ≥ 18 years old with prior untreated DLBCL

Who may be able to join

  • 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

Who cannot join

  • No available FFPE biopsy material or insufficient quality/quantity tumor samples according to prerequisite
  • No signed informed consent

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU Caen

    Caen, 14000

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU Le Bocage

    Dijon, 21034

  • CH Départemental

    La Roche-sur-Yon, 85925

  • CHU Claude Hurriez

    Lille, 59037

  • CHU Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • Centre Francois Magendie

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hôpital de la Miletrie

    Poitiers, 86021

  • Ch Annecy Genevois

    Pringy, 74370

  • Centre Henri Becquerel

    Rouen, 76038

  • IUCT Oncopôle - CHU de Toulouse

    Toulouse, 31059

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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.

Being tested
Biological samples collection
Keywords
DLBCL, Real time molecular characterization
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological samples collectionProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 38 days (i.e. 38 days after starting inductive chemotherapy regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2017
  2. Study start9 May 2017
  3. Primary completion11 Oct 2019
  4. Study completion4 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104478
Sponsor's protocol ID
RT3
Acronym
RT3
Status last verified
Dec 2021
First submitted
3 Apr 2017
Last updated
7 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real time report of molecular characterization (time frame: 38 days (i.e. 38 days after starting inductive chemotherapy regimen). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.

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