A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients
- Conditions
- NHL
- Registration Number
- NCT04139252
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tissue material 24 months For genomic analysis and clinical outcome data
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
NL-Almelo-ZGTALMELO
🇳🇱Almelo, Netherlands
NL-Deventer-DZ
🇳🇱Deventer, Netherlands
NL-Almere-FLEVOZIEKENHUIS
🇳🇱Almere, Netherlands
NL-Amstelveen-AMSTELLAND
🇳🇱Amstelveen, Netherlands
NL-Den Bosch-JBZ
🇳🇱Den Bosch, Netherlands
NL-Den Haag-HMCWESTEINDE
🇳🇱Den Haag, Netherlands
NL-Dordrecht-ASZ
🇳🇱Dordrecht, Netherlands
NL-Dirksland-VANWEELBETHESDA
🇳🇱Dirksland, Netherlands
NL-Ede-ZGV
🇳🇱Ede, Netherlands
NL-Emmen-SCHEPER
🇳🇱Emmen, Netherlands
NL-Enschede-MST
🇳🇱Enschede, Netherlands
NL-Geldrop-STANNA
🇳🇱Geldrop, Netherlands
NL-Heerenveen-TJONGERSCHANS
🇳🇱Heerenveen, Netherlands
NL-Hoofddorp-SPAARNEGASTHUIS
🇳🇱Hoofddorp, Netherlands
NL-Hoorn-DIJKLANDERHOORN
🇳🇱Hoorn, Netherlands
NL-Leeuwarden-MCL
🇳🇱Leeuwarden, Netherlands
NL-Tilburg-ETZ
🇳🇱Tilburg, Netherlands
NL-Zutphen-GELREZUTPHEN
🇳🇱Zutphen, Netherlands
NL-Gorinchem-BEATRIX
🇳🇱Gorinchem, Netherlands
NL-Leiden-LUMC
🇳🇱Leiden, Netherlands
NL-Nijmegen-CWZ
🇳🇱Nijmegen, Netherlands
NL-Rotterdam-SFG
🇳🇱Rotterdam, Netherlands
NL-Sneek-ANTONIUSSNEEK
🇳🇱Sneek, Netherlands
NL-Utrecht-UMCUTRECHT
🇳🇱Utrecht, Netherlands
NL-Venlo-VIECURI
🇳🇱Venlo, Netherlands
NL-Winterswijk-SKBWINTERSWIJK
🇳🇱Winterswijk, Netherlands
NL-Alkmaar-NWZ
🇳🇱Alkmaar, Netherlands
NL-Amersfoort-MEANDERMC
🇳🇱Amersfoort, Netherlands
NL-Amsterdam-AMC
🇳🇱Amsterdam, Netherlands
NL-Amsterdam-OLVG
🇳🇱Amsterdam, Netherlands
NL-Arnhem-RIJNSTATE
🇳🇱Arnhem, Netherlands
NL-Assen-WZA
🇳🇱Assen, Netherlands
NL-Beverwijk-RKZ
🇳🇱Beverwijk, Netherlands
NL-Capelle a/d IJssel-YSL
🇳🇱Capelle Aan Den IJssel, Netherlands
NL-Doetinchem-SLINGELAND
🇳🇱Doetinchem, Netherlands
NL-Goes-ADRZ
🇳🇱Goes, Netherlands
NL-Delft-RDGG
🇳🇱Delft, Netherlands
NL-Den Haag-HAGA
🇳🇱Den Haag, Netherlands
NL-Eindhoven-MAXIMAMC
🇳🇱Eindhoven, Netherlands
NL-Harderwijk-STJANSDALHARDERWIJK
🇳🇱Harderwijk, Netherlands
NL-Groningen-UMCG
🇳🇱Groningen, Netherlands
NL-Hardenberg-SAXENBURGH
🇳🇱Hardenberg, Netherlands
NL-Helmond-ELKERLIEK
🇳🇱Helmond, Netherlands
NL-Maastricht-MUMC
🇳🇱Maastricht, Netherlands
NL-Nieuwegein-ANTONIUS
🇳🇱Nieuwegein, Netherlands
NL-Roermond-LZR
🇳🇱Roermond, Netherlands
NL-Rotterdam-MAASSTADZIEKENHUIS
🇳🇱Rotterdam, Netherlands
NL-Roosendaal-BRAVIS
🇳🇱Roosendaal, Netherlands
NL-Rotterdam-IKAZIA
🇳🇱Rotterdam, Netherlands
NL-Uden-BERNHOVEN
🇳🇱Uden, Netherlands
NL-Tiel-RIVIERENLAND
🇳🇱Tiel, Netherlands
NL-Utrecht-DIAKONESSENUTRECHT
🇳🇱Utrecht, Netherlands
NL-Zwolle-ISALA
🇳🇱Zwolle, Netherlands
NL-Amsterdam-VUMC
🇳🇱Amsterdam, Netherlands
NL-Breda-AMPHIA
🇳🇱Breda, Netherlands
NL-Eindhoven-CATHARINA
🇳🇱Eindhoven, Netherlands
NL-Gouda-GROENEHART
🇳🇱Gouda, Netherlands
NL-Rotterdam-ERASMUSMC
🇳🇱Rotterdam, Netherlands
NL-Spijkenisse-SPIJKENISSEMC
🇳🇱Spijkenisse, Netherlands
NL-Terneuzen-ZORGSAAM
🇳🇱Terneuzen, Netherlands