HOVON HO44

Archived

Main info

Identifier:
HOVON 44 NHL
Sponsor:
HOVON
Included patients:
239
Active sites:
25
(of 25)
Title:

A randomized phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkin's lymphoma.

Timeline

Scheduled
Actual
2000
20 Nov
Activated
2005
23 Dec
ClosedForInclusionActualStart
2005
23 Dec
CloseoutInProgressLastPtOutActualStart
2015
23 Dec
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Malignant lymphoma based upon a representative histology specimen according to the REAL classification at relapse or progression: Follicular center lymphoma, follicular (grade III), Diffuse large B-cell lymphoma, Primary mediastinal B-cell lymphoma
  • CD20 positive
  • First progression or relapse during/after adriamycin containing regimen. *'Progressive' includes patients who have progressive disease (PD, without prior response) and patients who have progression after first PR
  • Age 18-65 years inclusive
  • WHO performance status 0 - 1 (see appendix E)
  • Witnessed written informed consent according to the center requirements
Exclusion Criteria:
  • Patients with history of intolerance of exogenous protein administration
  • Patients with severe cardiac dysfunction (NYHA classification II-IV, appendix F)
  • Patients with severe pulmonary dysfunction (vital capacity or diffusion capacity < 70% of predicted value) unless clearly related to NHL involvement
  • Patients with hepatic dysfunction, bilirubin or transaminase >= 2.5 x upper normal limit
  • Patients with renal dysfunction (serum creatinine >=180 mumol/l or clearance <=40 ml/min)
  • Prior treatment with immunotherapy or radiation therapy within the last month before entering the study
  • Patients with active uncontrolled infections
  • Patients known to be HIV-positive
  • Patients with NHL localization in the central nervous system
  • Patients with (EBV) post-transplant lymphoproliferative disorder

Participating Sites

Site
25 results
Order by
Accrual rate
Activation date
NL-Groningen-UMCG
45
NL-Amsterdam-VUMC
36
NL-Rotterdam-ERASMUSMC
27
NL-Rotterdam-EMCDANIEL
21
NL-Amsterdam-AMC
18
NL-Leiden-LUMC
16
NL-Den Haag-HAGA
15
NL-Utrecht-UMCUTRECHT
11
NL-Amersfoort-MEANDERMC
9
NL-Amsterdam-AVL
7
NL-Enschede-MST
6
NL-Amsterdam-OLVG
6
NL-Nieuwegein-ANTONIUS
6
NL-Dordrecht-ASZ
6
NL-Roosendaal-BRAVIS
2
NL-Utrecht-DIAKONESSENUTRECHT
2
NL-Zwolle-ISALA
2
NL-Den Haag-HMCBRONOVO
1
NL-Den Haag-HMCWESTEINDE
1
BE-Leuven-UZLEUVEN
1
NL-Amsterdam-SLOTERVAART
1
NL-Delft-RDGG
NL-Leidschendam-HMCANTONIUSHOVE
NL-Deventer-DZ
NL-Dirksland-VANWEELBETHESDA
= Active hospitals
= Inactive hospitals

Participating Parties

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