HOVON HO902 NHL

Closed

Main info

Identifier:
HO902 NHL
Sponsor:
HOVON
Working group party:
Lymphoma
Age:
>= 18
Stage:
1st Line
Echelon:
Level D
Included patients:
250
(of 250)
Active sites:
55
(of 62)
8 sites are pending
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 Mar
First Site
2020
20 Mar
FPI
2021
10 Aug
Activated
2021
10 Aug
ClosedForInclusionActualStart
2022
20 Sep
ClosedForInclusionScheduledStart
2025
20 Mar
CloseoutInProgressLastPtOutScheduledStart
2026
20 Mar
Archived

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

Participating Parties

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