A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients (HO902DLBCL)

April 25, 2023 updated by: Stichting Hemato-Oncologie voor Volwassenen Nederland

A National Study for Blood Based Response Monitoring of Newly Diagnosed Aggressive B-cell Lymphoma (DLBCL and HGBCL) Patients

Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. To make this possible, a crucial condition is optimal identification of patients that will not be cured on R-CHOP. The aim of this protocol is to develop new tools to monitor treatment response and disease outcome. Molecular monitoring of treatment response through liquid biopsies (LB) is such a promising new tool.

The primary objective is to collect liquid biopsy samples of patients with newly diagnosed DLBCL/HGBCL to develop a blood based assay allowing biomarker driven treatment in the future.

The secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay.

This study is designed for patients with newly diagnosed DLBCL and HGBCL ≥ 18 yr.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • NL-Alkmaar-NWZ
      • Almelo, Netherlands
        • NL-Almelo-ZGTALMELO
      • Almere, Netherlands
        • NL-Almere-FLEVOZIEKENHUIS
      • Amersfoort, Netherlands
        • NL-Amersfoort-MEANDERMC
      • Amstelveen, Netherlands
        • NL-Amstelveen-AMSTELLAND
      • Amsterdam, Netherlands
        • NL-Amsterdam-AMC
      • Amsterdam, Netherlands
        • NL-Amsterdam-OLVG
      • Amsterdam, Netherlands
        • NL-Amsterdam-VUMC
      • Arnhem, Netherlands
        • NL-Arnhem-RIJNSTATE
      • Assen, Netherlands
        • NL-Assen-WZA
      • Beverwijk, Netherlands
        • NL-Beverwijk-RKZ
      • Breda, Netherlands
        • NL-Breda-AMPHIA
      • Capelle Aan Den IJssel, Netherlands
        • NL-Capelle a/d IJssel-YSL
      • Delft, Netherlands
        • NL-Delft-RDGG
      • Den Bosch, Netherlands
        • NL-Den Bosch-JBZ
      • Den Haag, Netherlands
        • NL-Den Haag-HAGA
      • Den Haag, Netherlands
        • NL-Den Haag-HMCWESTEINDE
      • Deventer, Netherlands
        • NL-Deventer-DZ
      • Dirksland, Netherlands
        • NL-Dirksland-VANWEELBETHESDA
      • Doetinchem, Netherlands
        • NL-Doetinchem-SLINGELAND
      • Dordrecht, Netherlands
        • NL-Dordrecht-ASZ
      • Ede, Netherlands
        • NL-Ede-ZGV
      • Eindhoven, Netherlands
        • NL-Eindhoven-CATHARINA
      • Eindhoven, Netherlands
        • NL-Eindhoven-MAXIMAMC
      • Emmen, Netherlands
        • NL-Emmen-SCHEPER
      • Enschede, Netherlands
        • NL-Enschede-MST
      • Geldrop, Netherlands
        • NL-Geldrop-STANNA
      • Goes, Netherlands
        • NL-Goes-ADRZ
      • Gorinchem, Netherlands
        • NL-Gorinchem-BEATRIX
      • Gouda, Netherlands
        • NL-Gouda-GROENEHART
      • Groningen, Netherlands
        • NL-Groningen-UMCG
      • Hardenberg, Netherlands
        • NL-Hardenberg-SAXENBURGH
      • Harderwijk, Netherlands
        • NL-Harderwijk-STJANSDALHARDERWIJK
      • Heerenveen, Netherlands
        • NL-Heerenveen-TJONGERSCHANS
      • Helmond, Netherlands
        • NL-Helmond-ELKERLIEK
      • Hoofddorp, Netherlands
        • NL-Hoofddorp-SPAARNEGASTHUIS
      • Hoorn, Netherlands
        • NL-Hoorn-DIJKLANDERHOORN
      • Leeuwarden, Netherlands
        • NL-Leeuwarden-MCL
      • Leiden, Netherlands
        • NL-Leiden-LUMC
      • Maastricht, Netherlands
        • NL-Maastricht-MUMC
      • Nieuwegein, Netherlands
        • NL-Nieuwegein-ANTONIUS
      • Nijmegen, Netherlands
        • NL-Nijmegen-CWZ
      • Roermond, Netherlands
        • NL-Roermond-LZR
      • Roosendaal, Netherlands
        • NL-Roosendaal-BRAVIS
      • Rotterdam, Netherlands
        • NL-Rotterdam-ERASMUSMC
      • Rotterdam, Netherlands
        • NL-Rotterdam-IKAZIA
      • Rotterdam, Netherlands
        • NL-Rotterdam-MAASSTADZIEKENHUIS
      • Rotterdam, Netherlands
        • NL-Rotterdam-SFG
      • Sneek, Netherlands
        • NL-Sneek-ANTONIUSSNEEK
      • Spijkenisse, Netherlands
        • NL-Spijkenisse-SPIJKENISSEMC
      • Terneuzen, Netherlands
        • NL-Terneuzen-ZORGSAAM
      • Tiel, Netherlands
        • NL-Tiel-RIVIERENLAND
      • Tilburg, Netherlands
        • NL-Tilburg-ETZ
      • Uden, Netherlands
        • NL-Uden-BERNHOVEN
      • Utrecht, Netherlands
        • NL-Utrecht-DIAKONESSENUTRECHT
      • Utrecht, Netherlands
        • NL-Utrecht-UMCUTRECHT
      • Venlo, Netherlands
        • NL-Venlo-VIECURI
      • Winterswijk, Netherlands
        • NL-Winterswijk-SKBWINTERSWIJK
      • Zutphen, Netherlands
        • NL-Zutphen-GELREZUTPHEN
      • Zwolle, Netherlands
        • NL-Zwolle-ISALA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the eligibility criteria

Description

Inclusion Criteria:

  • Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016
  • Ann Arbor stage II-IV
  • Patients intended to be treated with 6 cycles R-CHOP (or DA-EPOCH-R) as first-line treatment (successive inclusion in HOVON 151 or HOVON 152 is possible)
  • Age ≥ 18 years

Exclusion Criteria:

- Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue material
Time Frame: 24 months
For genomic analysis and clinical outcome data
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Investigators

  • Principal Investigator: M.E.D. Chamuleau, MD, PhD, VUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HO902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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