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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 69 T-NHL

1. Overview
Study details
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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1. Overview


A phase II study of anti-CD52 monoclonal antibody (Alemtuzumab, MabCampath�) with 2-weekly CHOP chemotherapy (Camp-CHOP 14) in patients with mature T-cell non-Hodgkin�s lymphoma



Study details

Type of study

Prospective Phase II study

Target number of patients


Date of activation


Date closed


Approved by

EudraCTnr.: 2004-005031-26
METC UMCG 2005.101, 11 August 2005
CKTO, 4 November 2005

2. Patient eligibility criteria

Inclusion criteria

Patients with a confirmed histologic diagnosis of T-NHL according to the WHO classification:
a. Extranodal NK/T cell lymphoma, nasal type;
b. Enteropathy-type T-cell lymphoma (EATL), if measurable disease;
c. Subcutaneous panniculitis-like T-NHL;
d. Angioimmunoblastic T-cell lymphoma;
e. Peripheral T-cell lymphoma, unspecified (T-NHL NOS);
Age 18-65 years inclusive;
Ann Arbor stage II or more;
WHO performance status 0, 1 or 2;
Measurable disease;
Written informed consent

Exclusion criteria

Patients with NK/T-NHL of the following type:
a. Precursor T cell lymphoblastic lymphoma/leukemia;
b. All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL);
c. Anaplastic large cell lymphoma;
d. Hepatosplenic T cell lymphoma;
e. Enteropathy-type T cell lymphoma without measurable disease;
f. Blastic NK cell lymphoma;
Intolerance of exogenous protein administration;
Severe cardiac dysfunction (NYHA classification II-IV) 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;
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


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...:

Registration criteria

The following information will be requested:

Protocol number
Institution name
Name of caller/responsible investigator
Patient initials or code
Patient hospital record number
Date of birth
Date of diagnosis NHL
WHO NHL classification
PA number
Eligibility criteria

4. Participating parties

Principal investigator

Prof. Dr. J.C. Kluin-Nelemans(

Coordinating investigator(s)

G.W. van Imhoff (


W.L.J. van Putten (

Trial manager

M. Luten (

Central data management

M. Luten (

Other functions

Please contact monitors at

5. Participating sites

Included patients *
NL-Amersfoort-Meander MC
NL-Amstelveen-Ziekenhuis Amstelland
NL-Amsterdam-Antoni van Leeuwenhoek ZH
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
NL-Enschede-Medisch Spectrum Twente
NL-Leeuwarden-MC Leeuwarden Zuid
Show 9 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


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