HOVON HO63

Archived

Main info

Identifier:
HOVON 63 NHL
Sponsor:
HOVON
Included patients:
40
Active sites:
31
(of 31)
Title:

Randomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk Diffuse Large B-Cell Lymphoma.

Timeline

Scheduled
Actual
2005
28 Oct
Activated
2008
25 Mar
CloseoutInProgressLastPtOutActualStart
2018
25 Mar
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification;
  • Ann Arbor stage II-IV;
  • High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3);
  • DLBCL must be CD20 positive;
  • Age 18-65 years inclusive;
  • WHO performance status <= 2;
  • Negative preganacy test (if applicable);
  • 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 creatinine >= 150 mmol/l), unless related to NHL;
  • Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
  • Suspected or documented Central Nervous System involvement by NHL;
  • Testicular DLBCL;
  • Primary mediastinal B cell lymphoma;
  • Patients known to be HIV-positive;
  • Patients with active, uncontrolled infections;
  • Patients with uncontrolled asthma or allergy, requiring steroid treatment;
  • Patient is a lactating woman;
  • Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women);
  • Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk and not in excess of 900 mg/m^2 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;

Participating Sites

Site
31 results
Order by
Accrual rate
Activation date
NL-Amsterdam-AMC
5
NL-Amsterdam-VUMC
4
NL-Nieuwegein-ANTONIUS
4
NL-Dordrecht-ASZ
3
NL-Delft-RDGG
3
NL-Rotterdam-ERASMUSMC
3
NL-Leidschendam-HMCANTONIUSHOVE
2
NL-Den Haag-HAGA
2
NL-Rotterdam-EMCDANIEL
2
NL-Groningen-UMCG
2
NL-Zwolle-ISALA
2
NL-Amersfoort-MEANDERMC
2
NL-Den Bosch-JBZ
1
NL-Rotterdam-MAASSTADZIEKENHUIS
1
NL-Amsterdam-AVL
1
NL-Amsterdam-OLVG
1
NL-Utrecht-UMCUTRECHT
1
NL-Leeuwarden-MCL
1
NL-Den Haag-HMCWESTEINDE
NL-Nijmegen-CWZ
NL-Drachten-NIJSMELLINGHE
NL-Utrecht-DIAKONESSENUTRECHT
NL-Heerlen-ATRIUMMC
NL-Amstelveen-AMSTELLAND
NL-Hoofddorp-SPAARNEGASTHUIS
NL-Leiden-LUMC
NL-Arnhem-RIJNSTATE
NL-Maastricht-MUMC
NL-Enschede-MST
NL-Nijmegen-RADBOUDUMC
NL-Sittard-Geleen-ZUYDERLAND
= Active hospitals
= Inactive hospitals

Participating Parties

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