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

NCT ID: NCT04139252

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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

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NHL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M.E.D. Chamuleau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VUmc

Locations

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NL-Den Bosch-JBZ

's-Hertogenbosch, , Netherlands

Site Status

NL-Alkmaar-NWZ

Alkmaar, , Netherlands

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NL-Almelo-ZGTALMELO

Almelo, , Netherlands

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NL-Almere-FLEVOZIEKENHUIS

Almere Stad, , Netherlands

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NL-Amersfoort-MEANDERMC

Amersfoort, , Netherlands

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NL-Amstelveen-AMSTELLAND

Amstelveen, , Netherlands

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NL-Amsterdam-AMC

Amsterdam, , Netherlands

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NL-Amsterdam-OLVG

Amsterdam, , Netherlands

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NL-Amsterdam-VUMC

Amsterdam, , Netherlands

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NL-Arnhem-RIJNSTATE

Arnhem, , Netherlands

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NL-Assen-WZA

Assen, , Netherlands

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NL-Beverwijk-RKZ

Beverwijk, , Netherlands

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NL-Breda-AMPHIA

Breda, , Netherlands

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NL-Capelle a/d IJssel-YSL

Capelle aan den IJssel, , Netherlands

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NL-Delft-RDGG

Delft, , Netherlands

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NL-Deventer-DZ

Deventer, , Netherlands

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NL-Dirksland-VANWEELBETHESDA

Dirksland, , Netherlands

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NL-Doetinchem-SLINGELAND

Doetinchem, , Netherlands

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NL-Dordrecht-ASZ

Dordrecht, , Netherlands

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NL-Ede-ZGV

Ede, , Netherlands

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NL-Eindhoven-CATHARINA

Eindhoven, , Netherlands

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NL-Eindhoven-MAXIMAMC

Eindhoven, , Netherlands

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NL-Emmen-SCHEPER

Emmen, , Netherlands

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NL-Enschede-MST

Enschede, , Netherlands

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NL-Geldrop-STANNA

Geldrop, , Netherlands

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NL-Goes-ADRZ

Goes, , Netherlands

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NL-Gorinchem-BEATRIX

Gorinchem, , Netherlands

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NL-Gouda-GROENEHART

Gouda, , Netherlands

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NL-Groningen-UMCG

Groningen, , Netherlands

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NL-Hardenberg-SAXENBURGH

Hardenberg, , Netherlands

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NL-Harderwijk-STJANSDALHARDERWIJK

Harderwijk, , Netherlands

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NL-Heerenveen-TJONGERSCHANS

Heerenveen, , Netherlands

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NL-Helmond-ELKERLIEK

Helmond, , Netherlands

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NL-Hoofddorp-SPAARNEGASTHUIS

Hoofddorp, , Netherlands

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NL-Hoorn-DIJKLANDERHOORN

Hoorn, , Netherlands

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NL-Leeuwarden-MCL

Leeuwarden, , Netherlands

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NL-Leiden-LUMC

Leiden, , Netherlands

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NL-Maastricht-MUMC

Maastricht, , Netherlands

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NL-Nieuwegein-ANTONIUS

Nieuwegein, , Netherlands

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NL-Nijmegen-CWZ

Nijmegen, , Netherlands

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NL-Roermond-LZR

Roermond, , Netherlands

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NL-Roosendaal-BRAVIS

Roosendaal, , Netherlands

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NL-Rotterdam-ERASMUSMC

Rotterdam, , Netherlands

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NL-Rotterdam-IKAZIA

Rotterdam, , Netherlands

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NL-Rotterdam-MAASSTADZIEKENHUIS

Rotterdam, , Netherlands

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NL-Rotterdam-SFG

Rotterdam, , Netherlands

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NL-Sneek-ANTONIUSSNEEK

Sneek, , Netherlands

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NL-Spijkenisse-SPIJKENISSEMC

Spijkenisse, , Netherlands

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NL-Terneuzen-ZORGSAAM

Terneuzen, , Netherlands

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NL-Den Haag-HAGA

The Hague, , Netherlands

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NL-Den Haag-HMCWESTEINDE

The Hague, , Netherlands

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NL-Tiel-RIVIERENLAND

Tiel, , Netherlands

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NL-Tilburg-ETZ

Tilburg, , Netherlands

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NL-Uden-BERNHOVEN

Uden, , Netherlands

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NL-Utrecht-DIAKONESSENUTRECHT

Utrecht, , Netherlands

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NL-Utrecht-UMCUTRECHT

Utrecht, , Netherlands

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NL-Venlo-VIECURI

Venlo, , Netherlands

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NL-Winterswijk-SKBWINTERSWIJK

Winterswijk, , Netherlands

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NL-Zutphen-GELREZUTPHEN

Zutphen, , Netherlands

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NL-Zwolle-ISALA

Zwolle, , Netherlands

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Countries

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Netherlands

Other Identifiers

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HO902

Identifier Type: -

Identifier Source: org_study_id

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