HOVON HO46

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Main info

Identificatie:
HOVON 46 NHL
Sponsor:
HOVON
Included patients:
268
Active sites:
0
(of 51)
51 sites are pending
Title:

A randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy in elderly patients with intermediate- or high-risk non-Hodgkin?s lymphoma.

Timeline

Scheduled
Actual
2001
28 nov.
Activated
2005
06 sep.
Closeout in Progress
2015
06 sep.
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Patients with a confirmed histologic diagnosis of NHL according to the WHO classification (Appendix A):

a. Mantle cell lymphoma (MCL)
b. Follicular lymphoma (grade III) (FL III)
c. Diffuse large B-cell lymphoma (DLBCL)

  • Low-intermediate, high-intermediate or high risk NHL according to age-adjusted IPI score (appendix G)
  • NHL must be CD20 positive.
  • Age >= 65 years
  • WHO performance status <= 2 (see appendix E)
  • Written informed consent.
Exclusion Criteria:
  • Intolerance of exogenous protein administration

Severe cardiac dysfunction (NYHA classification II-IV, appendix F) or LVEF < 45 %

  • Significant renal dysfunction (serum creatinin >= 150 umol/l), unless related to NHL
  • Significant hepatic dysfunction (total bilirubin >= 30 umol/l or transaminases >= 2.5 times normal level), unless related to NHL
  • Suspected or documented Central Nervous System involvement by NHL
  • Patients known to be HIV-positive
  • Patients with active, uncontrolled infections
  • Patients with uncontrolled asthma or allergy, requiring steroid treatment
  • Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration
  • History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Participating Sites

Site
51 results
Order by
Accrual rate
Activation date
NL-Nieuwegein-ANTONIUS
19
NL-Rotterdam-ERASMUSMC
18
NL-Amsterdam-VUMC
17
NO-Oslo-RADIUM
15
SE-Lund-SUH
12
NL-Zwolle-ISALA
11
NL-Amersfoort-MEANDERMC
10
NL-Amsterdam-AMC
9
NL-Den Haag-HAGA
9
NL-Rotterdam-EMCDANIEL
8
NL-Enschede-MST
8
SE-Sundsvall-RVN
7
NL-Rotterdam-MAASSTADZIEKENHUIS
7
NL-Utrecht-DIAKONESSENUTRECHT
6
NL-Delft-RDGG
6
NL-Dordrecht-ASZ
5
NL-Meppel-ISALADIACONESSEN
5
SE-Halmstad-HALLANDS
5
NO-Stavanger-HELSESTAVANGER
5
NL-Leidschendam-HMCANTONIUSHOVE
5
SE-Luleå-SUNDERBY
4
BE-Leuven-UZLEUVEN
4
NL-Amsterdam-AVL
3
NL-Delfzijl-OMMELANDERDELFZIJL
3
SE-Goteborg-SAHLGRENSKA
3
SE-Uppsala-UPPSALAUH
3
NL-Stadskanaal-TRENTREFAJA
3
NL-Apeldoorn-GELREAPELDOORN
3
SE-Malmö-UMAS
3
NL-Hengelo-ZGTHENGELO
3
NL-Den Haag-HMCWESTEINDE
3
NL-Breda-AMPHIA
2
NL-Utrecht-UMCUTRECHT
2
NL-Capelle a/d IJssel-YSL
2
NL-Groningen-MARTINI
2
FI-Turku-TYKS
2
NL-Venlo-VIECURI
2
NL-Groningen-UMCG
2
NL-Haarlem-SPAARNEHAARLEM
2
NL-Helmond-ELKERLIEK
2
NL-Den Bosch-JBZ
2
NL-Emmen-SCHEPER
2
SE-Linköping-REGIONOSTERGOTLAND
1
NL-Vlaardingen-VLIETLANDVLARDINGEN
1
NL-Leiden-ALRIJNLEIDEN
1
NL-Roosendaal-BRAVIS
1
NL-Goes-ADRZ
1
NO-Tromsø-NORTHNOORWEGEN
1
NO-Bergen-HELSEBERGEN
1
NL-Amsterdam-SLOTERVAART
1
SE-Stockholm-KAROLINSKASOLNA
= Active hospitals
= Inactive hospitals

Participating Parties

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