HO902DLBCL: A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Tissue material [24 months]
For genomic analysis and clinical outcome data
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016
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Ann Arbor stage II-IV
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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)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NL-Alkmaar-NWZ | Alkmaar | Netherlands | ||
| 2 | NL-Almelo-ZGTALMELO | Almelo | Netherlands | ||
| 3 | NL-Almere-FLEVOZIEKENHUIS | Almere | Netherlands | ||
| 4 | NL-Amersfoort-MEANDERMC | Amersfoort | Netherlands | ||
| 5 | NL-Amstelveen-AMSTELLAND | Amstelveen | Netherlands | ||
| 6 | NL-Amsterdam-AMC | Amsterdam | Netherlands | ||
| 7 | NL-Amsterdam-OLVG | Amsterdam | Netherlands | ||
| 8 | NL-Amsterdam-VUMC | Amsterdam | Netherlands | ||
| 9 | NL-Arnhem-RIJNSTATE | Arnhem | Netherlands | ||
| 10 | NL-Assen-WZA | Assen | Netherlands | ||
| 11 | NL-Beverwijk-RKZ | Beverwijk | Netherlands | ||
| 12 | NL-Breda-AMPHIA | Breda | Netherlands | ||
| 13 | NL-Capelle a/d IJssel-YSL | Capelle Aan Den IJssel | Netherlands | ||
| 14 | NL-Delft-RDGG | Delft | Netherlands | ||
| 15 | NL-Den Bosch-JBZ | Den Bosch | Netherlands | ||
| 16 | NL-Den Haag-HAGA | Den Haag | Netherlands | ||
| 17 | NL-Den Haag-HMCWESTEINDE | Den Haag | Netherlands | ||
| 18 | NL-Deventer-DZ | Deventer | Netherlands | ||
| 19 | NL-Dirksland-VANWEELBETHESDA | Dirksland | Netherlands | ||
| 20 | NL-Doetinchem-SLINGELAND | Doetinchem | Netherlands | ||
| 21 | NL-Dordrecht-ASZ | Dordrecht | Netherlands | ||
| 22 | NL-Ede-ZGV | Ede | Netherlands | ||
| 23 | NL-Eindhoven-CATHARINA | Eindhoven | Netherlands | ||
| 24 | NL-Eindhoven-MAXIMAMC | Eindhoven | Netherlands | ||
| 25 | NL-Emmen-SCHEPER | Emmen | Netherlands | ||
| 26 | NL-Enschede-MST | Enschede | Netherlands | ||
| 27 | NL-Geldrop-STANNA | Geldrop | Netherlands | ||
| 28 | NL-Goes-ADRZ | Goes | Netherlands | ||
| 29 | NL-Gorinchem-BEATRIX | Gorinchem | Netherlands | ||
| 30 | NL-Gouda-GROENEHART | Gouda | Netherlands | ||
| 31 | NL-Groningen-UMCG | Groningen | Netherlands | ||
| 32 | NL-Hardenberg-SAXENBURGH | Hardenberg | Netherlands | ||
| 33 | NL-Harderwijk-STJANSDALHARDERWIJK | Harderwijk | Netherlands | ||
| 34 | NL-Heerenveen-TJONGERSCHANS | Heerenveen | Netherlands | ||
| 35 | NL-Helmond-ELKERLIEK | Helmond | Netherlands | ||
| 36 | NL-Hoofddorp-SPAARNEGASTHUIS | Hoofddorp | Netherlands | ||
| 37 | NL-Hoorn-DIJKLANDERHOORN | Hoorn | Netherlands | ||
| 38 | NL-Leeuwarden-MCL | Leeuwarden | Netherlands | ||
| 39 | NL-Leiden-LUMC | Leiden | Netherlands | ||
| 40 | NL-Maastricht-MUMC | Maastricht | Netherlands | ||
| 41 | NL-Nieuwegein-ANTONIUS | Nieuwegein | Netherlands | ||
| 42 | NL-Nijmegen-CWZ | Nijmegen | Netherlands | ||
| 43 | NL-Roermond-LZR | Roermond | Netherlands | ||
| 44 | NL-Roosendaal-BRAVIS | Roosendaal | Netherlands | ||
| 45 | NL-Rotterdam-ERASMUSMC | Rotterdam | Netherlands | ||
| 46 | NL-Rotterdam-IKAZIA | Rotterdam | Netherlands | ||
| 47 | NL-Rotterdam-MAASSTADZIEKENHUIS | Rotterdam | Netherlands | ||
| 48 | NL-Rotterdam-SFG | Rotterdam | Netherlands | ||
| 49 | NL-Sneek-ANTONIUSSNEEK | Sneek | Netherlands | ||
| 50 | NL-Spijkenisse-SPIJKENISSEMC | Spijkenisse | Netherlands | ||
| 51 | NL-Terneuzen-ZORGSAAM | Terneuzen | Netherlands | ||
| 52 | NL-Tiel-RIVIERENLAND | Tiel | Netherlands | ||
| 53 | NL-Tilburg-ETZ | Tilburg | Netherlands | ||
| 54 | NL-Uden-BERNHOVEN | Uden | Netherlands | ||
| 55 | NL-Utrecht-DIAKONESSENUTRECHT | Utrecht | Netherlands | ||
| 56 | NL-Utrecht-UMCUTRECHT | Utrecht | Netherlands | ||
| 57 | NL-Venlo-VIECURI | Venlo | Netherlands | ||
| 58 | NL-Winterswijk-SKBWINTERSWIJK | Winterswijk | Netherlands | ||
| 59 | NL-Zutphen-GELREZUTPHEN | Zutphen | Netherlands | ||
| 60 | NL-Zwolle-ISALA | Zwolle | Netherlands |
Sponsors and Collaborators
- Stichting Hemato-Oncologie voor Volwassenen Nederland
Investigators
- Principal Investigator: M.E.D. Chamuleau, MD, PhD, VUmc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HO902