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Trial record 1 of 1 for:    NCT03104478
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Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL) (RT3)

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ClinicalTrials.gov Identifier: NCT03104478
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Tracking Information
First Submitted Date April 3, 2017
First Posted Date April 7, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date May 9, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2017)
Real time report of molecular characterization [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03104478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
Official Title Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples are collected at time of enrollment in the trial.
Sampling Method Probability Sample
Study Population Patient ≥ 18 years old with prior untreated DLBCL
Condition Diffuse Large B Cell Lymphoma
Intervention Procedure: Biological samples collection
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2017)
194
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christine Stephan 04 72 66 93 33 christine.stephan@lysarc.org
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03104478
Other Study ID Numbers RT3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Lymphoma Academic Research Organisation
Study Sponsor The Lymphoma Academic Research Organisation
Collaborators Not Provided
Investigators
Principal Investigator: Fabrice Jardin, Pr Lymphoma Study Association
Principal Investigator: Christiane Copie, Pr Lymphoma Study Association
PRS Account The Lymphoma Academic Research Organisation
Verification Date March 2019