sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 69 T-NHL


News
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


return to top

News


No news


1. Overview



Summary

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


Status

closed



Study details



Type of study

Prospective Phase II study


Target number of patients

20


Date of activation

16-Nov-2005


Date closed

01-Nov-2007


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



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 initials or code
Patient hospital record number
Sex
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(j.c.kluin.nelemans@int.umcg.nl)


Coordinating investigator(s)

G.W. van Imhoff (g.w.van.imhoff@int.umcg.nl)


Statistician(s)

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


Trial manager

M. Luten (m.luten@erasmusmc.nl)


Central data management

M. Luten (m.luten@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



return to top