HOVON HO84 NHL

Closed

Main info

Identifier:
HO84 NHL
Sponsor:
HOVON
Working group party:
Lymphoma
Age:
18-80
Stage:
1st Line
Echelon:
Level D
Included patients:
600
(of 600)
Active sites:
68
(of 87)
Title:

Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in patients with diffuse large B-cell lymphoma

Timeline

Scheduled
Actual
2006
23 May
Opportunity
2007
23 May
Activated
2007
23 May
EC Approval
2007
30 Oct
First Site
2007
14 Nov
FPI
2013
04 Jun
ClosedForInclusionActualStart
2022
06 Apr
CloseoutInProgressLastPtOutScheduledStart
2023
06 Apr
Archived

News

Updated documents:

  • 5 mar 2013: Nieuwe versie WMO-verklaring; Einddatum verzekering gewijzigd van dec2012 naar dec2014.
  • 14 jan 2013: Nieuwe versie Rituximab Bestelfax.

April 10, 2012:

  • The study is closed for inclusion of new patients, because the target (600 patients) has been reached. The randomization for maintenance treatment will not be closed before the last patient has reached this timepoint.

Updated documents:

  • 12oct2011: a new version of the FAQ sheet is added.
  • 6sep2011: Nieuwe versie CRFs (versie 5, 1SEP2011). In deze versie zijn 3 vragen uit het Informed Consent en 1 vraag over het nieuwe PK Informed Consent toegevoegd. Vanaf heden graag alleen deze versie gebruiken voor ALLE patienten. (Het SAE form is niet gewijzigd.)

6 sep 2011:

  • Addendum Pharmacokinetic Evaluation Rituximab geaktiveerd (Amendement 5, alleen NL). Deze Rituximab PK Side Study in 40 HOVON84 patienten, zal slechts in 9 NL centra gaan lopen (Erasmus MC, VUMC, Amphia, Jeroen Bosch, Haga, Alb. Schweizer, UMCG, MCL Antonius). De overige NL/B/DK centra hoeven dus geen aktie te ondernemen. Alle PK specifieke documenten (PK Addendum, PK ICF template, METC goedkeuring amendement, Site Documents Checklist AM5:PK addendum) zijn vanaf vandaag te downloaden vanaf de website.

Updated documents:

  • 7jul2011: FAQ voor datamanagers is toegevoegd.
  • 22 jun 2010: Nieuwe versie SAE form (versie 03, 22JUN2010) en nieuwe versie SAE report instructions (versie 04, 27APR2010)
  • 25 mar 2010: Nieuwe versie Flowchart Clinical Evaluations (versie AM1)
  • 21 jan 2010: Nieuwe versie Rituximab Bestelfax.
  • 13 okt 09: nieuwe versie CRFs (versie 4, 12okt2009). In deze versie zijn enkele fouten in het 'Registratie&Randomization Form (1)' gecorrigeerd.

Amendement 1:

  • Amendement 1 is op 16 september 2009 goedgekeurd door de nederlandse centrale METC (Erasmus MC). De belangrijkste wijzigingen in dit amendement zijn:
    • Het terugbrengen van het aantal twee-wekelijkse rituximab-CHOP kuren van 8 naar 6 voor oudere patienten (66-80 jaar) (Opm.: al aktief sinds juli 2009)
    • Het includeren van jongere patienten (18-65 jaar) met een aa-IPI van 1-3
    • Kleine wijziging in de centrale PET review procedure
    • De evaluatie van de respons blijft op dezelfde momenten plaatsvinden, dus na 4 kuren en na de laatste kuur.
  • Dit amendement is in Nederland vanaf donderdag 1 oktober 2009 aktief. Momenteel is het amendment ook in Belgie en Denemarken aktief. Dat betekent dat alle centra óók jongere patienten(18-65 jaar) mogen includeren. Het terugbrengen van het aantal R-CHOP kuren was al eerder geadviseerd (mailing juli 2009)

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Not any more
Objectives:

To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL:

  • The effect of early intensification of rituximab combined with 2-weekly CHOP +G-CSF (CHOP14) in comparison to no intensification of rituximab on the response rate (complete remission and FDG-PET negative partial remission/unconfirmed complete remission) and time to reach response
  • The efficacy of maintenance treatment with rituximab in comparison to no further treatment on failure free survival

Eligibility

Inclusion Criteria:
  • Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification (see protocol appendix A)
  • DLBCL must be CD20 positive
  • Ann Arbor stages II-IV (see protocol appendix C)
  • Age 18-65 (inclusive) years and aa-IPI 1-3 (see protocol appendix G) OR Age 66-80 (inclusive) years and aa-IPI 0-3 (see protocol appendix G)
  • WHO performance status 0 – 2 (see protocol appendix E)
  • Written informed consent
Exclusion Criteria:
  • Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors, see protocol appendix G)
  • Intolerance of exogenous protein administration
  • Severe cardiac dysfunction (NYHA classification III-IV, see protocol appendix F) or LVEF < 45%. Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months
  • Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
  • Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
  • Significant hepatic dysfunction (total bilirubin ≥ 30µmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL
  • Significant renal dysfunction (serum creatinine ≥ 150 µmol/l or clearance ≤ 60 ml/min), unless related to NHL
  • Clinical signs of severe cerebral dysfunction
  • Suspected or documented Central Nervous System involvement by NHL
  • Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
  • Testicular DLBCL
  • Primary mediastinal B cell lymphoma
  • Transformed indolent lymphoma
  • (EBV) post-transplant lymphoproliferative disorder
  • Secondary lymphoma after previous chemotherapy or radiotherapy
  • Major surgery, other than diagnostic surgery, within the last 4 weeks
  • Patients with active uncontrolled infections
  • Patients known to be HIV-positive
  • Active chronic hepatitis B or C infection
  • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
  • Life expectancy < 6 months
  • Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 week) and/or cyclophosphamide (< 1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms
  • History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Registration Details

The patient should be registered immediately after satisfactory completion of screening tests and obtaining informed consent, and before the start of chemotherapy.
Patients need to be registered at the HOVON Data Center of the Erasmus MC - Daniel den Hoed

  • by phone call: +31.10.7041560 or fax +31.10.7041028 Monday through Friday, from 09:00 to 17:00, or
  • via the Internet through TOP (Trial Online Process; https://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.

Follow up 1x per jaar, tot 10 jaar na randomisatie.

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
68 results
Order by
Accrual rate
Activation date
DK-Copenhagen-RIGSHOSPITALET
31
17 Mar 2009
DK-Aarhus N-AUH
28
12 Feb 2009
NL-Nieuwegein-ANTONIUS
26
20 Mar 2008
NL-Dordrecht-ASZ
25
14 Jan 2008
NL-Amersfoort-MEANDERMC
21
08 Jul 2008
NL-Breda-AMPHIA
20
09 Jan 2009
NL-Den Haag-HAGA
19
14 Nov 2007
NL-Den Bosch-JBZ
19
24 Apr 2008
NL-Leeuwarden-MCL
16
19 Feb 2008
BE-Leuven-UZLEUVEN
16
21 Oct 2008
NL-Goes-ADRZ
15
24 Sep 2008
NL-Roosendaal-BRAVIS
14
NL-Groningen-UMCG
14
25 Nov 2008
NL-Heerlen-ATRIUMMC
13
01 Apr 2008
NL-Nijmegen-CWZ
13
25 Jul 2008
NL-Hilversum-TERGOOI
13
05 Oct 2010
NL-Amsterdam-VUMC
13
14 Nov 2007
DK-Odense-OUH
13
11 May 2010
DK-Roskilde-ROSKILDE
13
16 Jun 2009
NL-Maastricht-MUMC
12
19 Dec 2008
NL-Hoofddorp-SPAARNEGASTHUIS
12
23 Sep 2008
NL-Rotterdam-MAASSTADZIEKENHUIS
12
04 Nov 2008
NL-Zwolle-ISALA
11
20 Jan 2010
BE-Antwerpen-ZNASTUIVENBERG
10
12 Jul 2010
NL-Delft-RDGG
9
30 Nov 2007
NL-Amsterdam-AMC
9
30 Oct 2007
NL-Rotterdam-ERASMUSMC
8
13 Feb 2008
NL-Eindhoven-MAXIMAMC
8
04 Jan 2010
NL-Roermond-LZR
8
30 Jul 2009
NL-Amsterdam-AVL
8
28 Dec 2007
NL-Sittard-Geleen-ZUYDERLAND
7
25 Mar 2010
NL-Rotterdam-EMCDANIEL
7
13 Mar 2008
DK-Holstebro-HOLSTEBRO
6
19 May 2009
DK-Viborg-MIDTVIBORG
6
23 Apr 2009
DK-Vejle-VEJLESYGEHUS
6
29 Apr 2010
NL-Utrecht-UMCUTRECHT
6
18 Oct 2010
DK-Aalborg-AALBORGUH
6
09 Feb 2009
NL-Schiedam-FRANCISCUSVLIETLAND
6
25 Jun 2008
NL-Tilburg-ETZ
6
23 Jul 2008
NL-Leiden-LUMC
6
23 Nov 2009
NL-Enschede-MST
5
21 Apr 2009
NL-Zaandam-ZAANSMC
5
04 Feb 2010
NL-Nijmegen-RADBOUDUMC
5
09 Apr 2009
NL-Amsterdam-OLVG
5
18 Feb 2008
NL-Deventer-DZ
5
07 Aug 2008
NL-Rotterdam-IKAZIA
5
04 Nov 2008
DK-Herlev-HERLEV
4
07 Apr 2011
NL-Haarlem-SPAARNEHAARLEM
4
03 Mar 2011
NL-Groningen-MARTINI
4
24 Jun 2010
NL-Amsterdam-SLAZLUCAS
4
20 Jun 2008
NL-Beverwijk-RKZ
4
09 Jul 2009
NL-Arnhem-RIJNSTATE
4
06 Jul 2009
NL-Gouda-GROENEHART
4
30 Mar 2009
NL-Spijkenisse-SPIJKENISSEMC
4
02 Jul 2009
NL-Capelle a/d IJssel-YSL
3
16 Feb 2009
NL-Gorinchem-BEATRIX
3
07 Apr 2009
NL-Amsterdam-SLOTERVAART
3
25 Jun 2008
NL-Apeldoorn-GELREAPELDOORN
3
24 Mar 2009
NL-Lelystad-STJANSDALLELYSTAD
2
27 Jan 2009
NL-Rotterdam-SFG
2
11 Jun 2008
NL-Almelo-ZGTALMELO
2
21 Apr 2009
NL-Amstelveen-AMSTELLAND
2
11 Sep 2008
NL-Winterswijk-SKBWINTERSWIJK
2
07 Aug 2008
NL-Den Haag-HMCBRONOVO
1
14 Mar 2008
NL-Dirksland-VANWEELBETHESDA
1
13 Jan 2009
NL-Ede-ZGV
1
20 Sep 2011
NL-Tiel-RIVIERENLAND
1
24 Aug 2010
NL-Leidschendam-HMCANTONIUSHOVE
23 Apr 2008
= Active hospitals
= Inactive hospitals

Participating Parties

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