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

NHL Clinical Trial

— HO902DLBCL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04139252
• Other study ID #: HO902
• Status: Active, not recruiting
• Start date: March 17, 2020
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Stichting Hemato-Oncologie voor Volwassenen Nederland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• NHL

Intervention

Other:
• No intervention
No intervention

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stichting Hemato-Oncologie voor Volwassenen Nederland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue material	For genomic analysis and clinical outcome data	24 months