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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 46 NHL


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

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


Status

closed



Type of study

Prospective randomized Phase III study


Target number of patients

400


Current number of patients

265


Date of activation

28-Nov-2001


Date closed

06-Sep-2005


Approved by

CKVO: CKVO 2000-10, 09-07-2001
MEC: METC EUR/AZR 202.109/2001/120, 24-07-2001


Study objectives

To assess in a randomized comparison the efficacy of Rituximab combined with 2-weekly CHOP + G-CSF in comparison with 2-weekly CHOP + G-CSF alone, on event free survival.
As secondary objectives the effect of Rituximab on complete remission rate, overall survival and disease free survival will be evaluated.
To evaluate the toxicity of Rituximab with 2-weekly CHOP + G-CSF in comparison with 2-weekly CHOP + G-CSF alone.


2. Patient eligibility criteria



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


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient?s initials or code
Patient?s hospital record number
Sex
Date of birth
Date of diagnosis NHL
WHO classification (appendix A)
Age-adjusted IPI risk score
PA number
Eligibility criteria.


4. Participating parties



Principal Investigator(s)

Prof. Dr. P.C. Huijgens (VUMC)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)


Statistician(s)

Dhr. W.L.J. van Putten (Erasmus MC - Daniel)


Other functions

Reviewer - Pathology - Dhr. Dr. K.H. Lam (Erasmus MC - Centrum)
Reviewer - Pathology - Dr. C. Sundström (Uppsala Akademiska Sjukhuset)


Principal investigator

P. Sonneveld (p.sonneveld@erasmusmc.nl)


Coordinating investigator(s)

P.C. Huijgens (pc.huijgens@vumc.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

M.C.J. Testroote (m.testroote@erasmusmc.nl)


Central data management

M.C.J. Testroote (m.testroote@erasmusmc.nl)


Other functions

Central Pathologist:
K.H. Lam (k.lam@erasmusmc.nl)
D. de Jong (d.d.jong@nki.nl)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
4
FI-Turku-Turku University Central Hospital
2
NL-Amersfoort-Meander MC
10
NL-Amstelveen-Ziekenhuis Amstelland
0
NL-Amsterdam-AMC
9
NL-Amsterdam-Antoni van Leeuwenhoek ZH
3
NL-Amsterdam-Bovenij Ziekenhuis
0
NL-Amsterdam-OLVG
1
NL-Amsterdam-Slotervaart Ziekenhuis
1
NL-Amsterdam-VUMC
17
Show 65 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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