Clinical trial NCT04139252: A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients
Official title: A National Study for Blood Based Response Monitoring of Newly Diagnosed Aggressive B-cell Lymphoma (DLBCL and HGBCL) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NHL
Lead sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the eligibility criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tissue material
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: NL-Alkmaar-NWZ
city: Almelo
country: Netherlands
facility: NL-Almelo-ZGTALMELO
city: Almere
country: Netherlands
facility: NL-Almere-FLEVOZIEKENHUIS
city: Amersfoort
country: Netherlands
facility: NL-Amersfoort-MEANDERMC
city: Amstelveen
country: Netherlands
facility: NL-Amstelveen-AMSTELLAND
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-AMC
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-OLVG
city: Amsterdam
country: Netherlands
facility: NL-Amsterdam-VUMC
city: Arnhem
country: Netherlands
facility: NL-Arnhem-RIJNSTATE
city: Assen
country: Netherlands
facility: NL-Assen-WZA
city: Beverwijk
country: Netherlands
facility: NL-Beverwijk-RKZ
city: Breda
country: Netherlands
facility: NL-Breda-AMPHIA
city: Capelle Aan Den IJssel
country: Netherlands
facility: NL-Capelle a/d IJssel-YSL
city: Delft
country: Netherlands
facility: NL-Delft-RDGG
city: Den Bosch
country: Netherlands
facility: NL-Den Bosch-JBZ
city: Den Haag
country: Netherlands
facility: NL-Den Haag-HAGA
city: Den Haag
country: Netherlands
facility: NL-Den Haag-HMCWESTEINDE
city: Deventer
country: Netherlands
facility: NL-Deventer-DZ
city: Dirksland
country: Netherlands
facility: NL-Dirksland-VANWEELBETHESDA
city: Doetinchem
country: Netherlands
facility: NL-Doetinchem-SLINGELAND
city: Dordrecht
country: Netherlands
facility: NL-Dordrecht-ASZ
city: Ede
country: Netherlands
facility: NL-Ede-ZGV
city: Eindhoven
country: Netherlands
facility: NL-Eindhoven-CATHARINA
city: Eindhoven
country: Netherlands
facility: NL-Eindhoven-MAXIMAMC
city: Emmen
country: Netherlands
facility: NL-Emmen-SCHEPER
city: Enschede
country: Netherlands
facility: NL-Enschede-MST
city: Geldrop
country: Netherlands
facility: NL-Geldrop-STANNA
city: Goes
country: Netherlands
facility: NL-Goes-ADRZ
city: Gorinchem
country: Netherlands
facility: NL-Gorinchem-BEATRIX
city: Gouda
country: Netherlands
facility: NL-Gouda-GROENEHART
city: Groningen
country: Netherlands
facility: NL-Groningen-UMCG
city: Hardenberg
country: Netherlands
facility: NL-Hardenberg-SAXENBURGH
city: Harderwijk
country: Netherlands
facility: NL-Harderwijk-STJANSDALHARDERWIJK
city: Heerenveen
country: Netherlands
facility: NL-Heerenveen-TJONGERSCHANS
city: Helmond
country: Netherlands
facility: NL-Helmond-ELKERLIEK
city: Hoofddorp
country: Netherlands
facility: NL-Hoofddorp-SPAARNEGASTHUIS
city: Hoorn
country: Netherlands
facility: NL-Hoorn-DIJKLANDERHOORN
city: Leeuwarden
country: Netherlands
facility: NL-Leeuwarden-MCL
city: Leiden
country: Netherlands
facility: NL-Leiden-LUMC
city: Maastricht
country: Netherlands
facility: NL-Maastricht-MUMC
city: Nieuwegein
country: Netherlands
facility: NL-Nieuwegein-ANTONIUS
city: Nijmegen
country: Netherlands
facility: NL-Nijmegen-CWZ
city: Roermond
country: Netherlands
facility: NL-Roermond-LZR
city: Roosendaal
country: Netherlands
facility: NL-Roosendaal-BRAVIS
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-ERASMUSMC
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-IKAZIA
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-MAASSTADZIEKENHUIS
city: Rotterdam
country: Netherlands
facility: NL-Rotterdam-SFG
city: Sneek
country: Netherlands
facility: NL-Sneek-ANTONIUSSNEEK
city: Spijkenisse
country: Netherlands
facility: NL-Spijkenisse-SPIJKENISSEMC
city: Terneuzen
country: Netherlands
facility: NL-Terneuzen-ZORGSAAM
city: Tiel
country: Netherlands
facility: NL-Tiel-RIVIERENLAND
city: Tilburg
country: Netherlands
facility: NL-Tilburg-ETZ
city: Uden
country: Netherlands
facility: NL-Uden-BERNHOVEN
city: Utrecht
country: Netherlands
facility: NL-Utrecht-DIAKONESSENUTRECHT
city: Utrecht
country: Netherlands
facility: NL-Utrecht-UMCUTRECHT
city: Venlo
country: Netherlands
facility: NL-Venlo-VIECURI
city: Winterswijk
country: Netherlands
facility: NL-Winterswijk-SKBWINTERSWIJK
city: Zutphen
country: Netherlands
facility: NL-Zutphen-GELREZUTPHEN
city: Zwolle
country: Netherlands
facility: NL-Zwolle-ISALA
Study officials:
affiliation: VUmc
name: M.E.D. Chamuleau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: