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NHLHO902DLBCLNCT04139252

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

An observational study of NHL, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 60 sites in Netherlands.

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

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
NHL
How many people
250 participants
Where
60 sitesNetherlands
Study dates
17 Mar 2020to 15 Jan 2024
Phase
Observational

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who meet the eligibility criteria

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

Netherlands60 sites

  • NL-Den Bosch-JBZ

    's-Hertogenbosch

  • NL-Alkmaar-NWZ

    Alkmaar

  • NL-Almelo-ZGTALMELO

    Almelo

  • NL-Almere-FLEVOZIEKENHUIS

    Almere Stad

  • NL-Amersfoort-MEANDERMC

    Amersfoort

  • NL-Amstelveen-AMSTELLAND

    Amstelveen

  • NL-Amsterdam-AMC

    Amsterdam

  • NL-Amsterdam-OLVG

    Amsterdam

  • NL-Amsterdam-VUMC

    Amsterdam

  • NL-Arnhem-RIJNSTATE

    Arnhem

  • NL-Assen-WZA

    Assen

  • NL-Beverwijk-RKZ

    Beverwijk

  • NL-Breda-AMPHIA

    Breda

  • NL-Capelle a/d IJssel-YSL

    Capelle aan den IJssel

  • NL-Delft-RDGG

    Delft

  • NL-Deventer-DZ

    Deventer

  • NL-Dirksland-VANWEELBETHESDA

    Dirksland

  • NL-Doetinchem-SLINGELAND

    Doetinchem

  • NL-Dordrecht-ASZ

    Dordrecht

  • NL-Ede-ZGV

    Ede

  • NL-Eindhoven-CATHARINA

    Eindhoven

  • NL-Eindhoven-MAXIMAMC

    Eindhoven

  • NL-Emmen-SCHEPER

    Emmen

  • NL-Enschede-MST

    Enschede

  • NL-Geldrop-STANNA

    Geldrop

  • NL-Goes-ADRZ

    Goes

  • NL-Gorinchem-BEATRIX

    Gorinchem

  • NL-Gouda-GROENEHART

    Gouda

  • NL-Groningen-UMCG

    Groningen

  • NL-Hardenberg-SAXENBURGH

    Hardenberg

  • NL-Harderwijk-STJANSDALHARDERWIJK

    Harderwijk

  • NL-Heerenveen-TJONGERSCHANS

    Heerenveen

  • NL-Helmond-ELKERLIEK

    Helmond

  • NL-Hoofddorp-SPAARNEGASTHUIS

    Hoofddorp

  • NL-Hoorn-DIJKLANDERHOORN

    Hoorn

  • NL-Leeuwarden-MCL

    Leeuwarden

  • NL-Leiden-LUMC

    Leiden

  • NL-Maastricht-MUMC

    Maastricht

  • NL-Nieuwegein-ANTONIUS

    Nieuwegein

  • NL-Nijmegen-CWZ

    Nijmegen

  • NL-Roermond-LZR

    Roermond

  • NL-Roosendaal-BRAVIS

    Roosendaal

  • NL-Rotterdam-ERASMUSMC

    Rotterdam

  • NL-Rotterdam-IKAZIA

    Rotterdam

  • NL-Rotterdam-MAASSTADZIEKENHUIS

    Rotterdam

  • NL-Rotterdam-SFG

    Rotterdam

  • NL-Sneek-ANTONIUSSNEEK

    Sneek

  • NL-Spijkenisse-SPIJKENISSEMC

    Spijkenisse

  • NL-Terneuzen-ZORGSAAM

    Terneuzen

  • NL-Den Haag-HAGA

    The Hague

  • NL-Den Haag-HMCWESTEINDE

    The Hague

  • NL-Tiel-RIVIERENLAND

    Tiel

  • NL-Tilburg-ETZ

    Tilburg

  • NL-Uden-BERNHOVEN

    Uden

  • NL-Utrecht-DIAKONESSENUTRECHT

    Utrecht

  • NL-Utrecht-UMCUTRECHT

    Utrecht

  • NL-Venlo-VIECURI

    Venlo

  • NL-Winterswijk-SKBWINTERSWIJK

    Winterswijk

  • NL-Zutphen-GELREZUTPHEN

    Zutphen

  • NL-Zwolle-ISALA

    Zwolle

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
NHL
Being tested
No intervention

What participants receive

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

  • No interventionOther

    No intervention

What is being measured

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

  1. Tissue material

    For genomic analysis and clinical outcome data

    Measured: 24 months

Timeline

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

  1. First posted25 Oct 2019
  2. Study start17 Mar 2020
  3. Primary completion15 Jan 2024
  4. Study completion15 Jan 2024

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
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04139252
Sponsor's protocol ID
HO902
Acronym
HO902DLBCL
Status last verified
Oct 2026
First submitted
23 Oct 2019
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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