HOVON HO902 NHL

Gesloten

Main info

Identificatie:
HO902 NHL
Sponsor:
HOVON
Working group party:
Lymphoma
Age:
>= 18
Stadium:
1st lijn
Echelon:
Level D
Included patients:
250
(of 250)
Active sites:
55
(of 62)
Title:

A national study for blood based response monitoring of newly diagnosed aggressive B-cell lymphoma (DLBCL and HGBCL) patients

Timeline

Scheduled
Actual
2019
26 jul.
Opportunity
2019
01 aug.
Submission in Progress
2020
15 jan.
EC Approval
2020
17 mrt.
Activated
2020
17 mrt.
First Site
2020
20 mrt.
FPI
2021
10 aug.
ClosedForInclusionActualStart
2025
20 mrt.
Closeout in Progress
2026
20 mrt.
Archived
2039
02 feb.
Destruction

Flow

Flow

Details

Phase:
Observational Prospective
Monitoring Type:
Objectives:

The primary objective is to obtain LB samples to develop a reliable blood based assay that identifies primary refractory and early relapsing patients, thus enabling clinical interventional trial in the near future.

The secondary objectives are to collect clinical data and pre-treatment tissue samples to allow for determining molecular profiles and to allow for correlation to the blood based assay.

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

Registration Details

Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:

  • HOVON Data Center registration database (www.hovon.nl). Account for registration and a registration manual can be requested at HOVON Data Center.
  • By e-mailing the completed registration CRF to hdc@erasmusmc.nl Monday through Friday from 09:00 to 17:00 CET
  • By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00 CET

The following information will be requested at registration:

  • Protocol number
  • Institution name
  • Name of caller/responsible investigator
  • Sex
  • Year of birth or age at registration
  • Date written informed consent
  • Specific items for which this patient gives consent (see ICF)
  • Date of diagnosis
  • Diagnosis (DLBCL or HGBCL)
  • Stage II or III or IV
  • LDH and ULN
  • WHO performance status
  • Extranodal localizations 0 or ≥1
  • Name of the local pathology laboratory
  • Local pathology registration number
  • Scheduled date start treatment

Participating Sites

Ziekenhuizen die deelnemen aan het onderzoek staan benoemd op de HOVON website bij het onderzoek. Het kan zijn dat uw ziekenhuis niet genoemd wordt, maar wel aan het onderzoek deelneemt. Informeer hiernaar bij uw arts.

Site
55 results
Order by
Accrual rate
Activation date
NL-Zutphen-GELREZUTPHEN
18
10 jul. 2020
NL-Nijmegen-CWZ
15
17 mrt. 2020
NL-Breda-AMPHIA
13
22 apr. 2020
NL-Nieuwegein-ANTONIUS
13
24 jun. 2020
NL-Hoorn-DIJKLANDERHOORN
12
17 sep. 2020
NL-Dordrecht-ASZ
12
30 mrt. 2020
NL-Venlo-VIECURI
10
26 aug. 2020
NL-Den Bosch-JBZ
10
10 apr. 2020
NL-Goes-ADRZ
9
26 mei 2020
NL-Rotterdam-MAASSTADZIEKENHUIS
9
28 jul. 2020
NL-Roosendaal-BRAVIS
9
22 apr. 2020
NL-Uden-BERNHOVEN
8
29 apr. 2020
NL-Gorinchem-BEATRIX
7
07 jul. 2020
NL-Leeuwarden-MCL
7
24 apr. 2020
NL-Doetinchem-SLINGELAND
7
23 apr. 2020
NL-Ede-ZGV
7
14 jul. 2020
NL-Eindhoven-MAXIMAMC
6
05 aug. 2020
NL-Zwolle-ISALA
6
27 mei 2020
NL-Rotterdam-SFG
6
28 jul. 2020
NL-Den Haag-HAGA
6
07 mei 2020
NL-Hardenberg-SAXENBURGH
5
11 mei 2020
NL-Utrecht-UMCUTRECHT
4
25 jun. 2020
NL-Almere-FLEVOZIEKENHUIS
4
01 okt. 2020
NL-Rotterdam-IKAZIA
3
20 mei 2020
NL-Utrecht-DIAKONESSENUTRECHT
3
06 jul. 2020
NL-Gouda-GROENEHART
3
25 jun. 2020
NL-Delft-RDGG
3
03 sep. 2020
NL-Tilburg-ETZ
3
11 dec. 2020
NL-Hoofddorp-SPAARNEGASTHUIS
3
17 sep. 2020
NL-Eindhoven-CATHARINA
3
24 sep. 2020
NL-Dirksland-VANWEELBETHESDA
3
15 jul. 2020
NL-Amsterdam-AMC
2
28 jul. 2020
NL-Terneuzen-ZORGSAAM
2
15 sep. 2020
NL-Capelle a/d IJssel-YSL
2
03 sep. 2020
NL-Beverwijk-RKZ
2
24 sep. 2020
NL-Deventer-DZ
2
13 jul. 2020
NL-Amersfoort-MEANDERMC
2
16 jun. 2020
NL-Roermond-LZR
2
21 dec. 2020
NL-Sneek-ANTONIUSSNEEK
2
27 okt. 2020
NL-Winterswijk-SKBWINTERSWIJK
1
04 aug. 2020
NL-Leiden-LUMC
1
13 jan. 2021
NL-Assen-WZA
1
12 jan. 2021
NL-Harderwijk-STJANSDALHARDERWIJK
1
01 mrt. 2021
NL-Maastricht-MUMC
1
21 aug. 2020
NL-Rotterdam-ERASMUSMC
1
15 okt. 2020
NL-Almelo-ZGTALMELO
1
20 okt. 2020
NL-Leiderdorp-ALRIJNELEIDERDORP
15 jun. 2020
NL-Helmond-ELKERLIEK
27 mei 2021
NL-Spijkenisse-SPIJKENISSEMC
12 mei 2021
NL-Groningen-UMCG
20 nov. 2020
NL-Enschede-MST
21 dec. 2020
NL-Emmen-SCHEPER
17 apr. 2020
NL-Amstelveen-AMSTELLAND
26 apr. 2021
NL-Heerenveen-TJONGERSCHANS
27 aug. 2020
NL-Amsterdam-VUMC
31 mrt. 2020
= Active hospitals
= Inactive hospitals

Participating Parties

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