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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 44 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 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


Status

closed



Type of study

Prospective randomized Phase III study


Target number of patients

300


Current number of patients

232


Date of activation

20-Nov-2000


Date closed

23-Dec-2005


Approved by

CKVO: CKVO 2000-06, 19 September 2000
MEC: METc AZG, 11 September 2000


Change history / amendement

Amendment 1: 24 January 2003, Activated 19 February 2003


2. Patient eligibility criteria



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


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
Name institute
Name of caller/physician who treats the patient
Name or initials of patient
Hospital record number
Sex
Date of birth
Date of diagnosis of relapsed or progressive B-NHL
REAL classification
Best response during/after adriamycin containing regimen (CR, PR, no CR/PR)
Duration of previous resonse (<3 months vs >=3 months)
WHO performance status
Date last administration of previous immunotherapy or radiotherapy
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Prof. Dr. W.E. Fibbe (Leids Universitair Medisch Centrum)
Prof.Dr. E. Vellenga (UMCG)


Co-Investigator(s)

Prof. Dr. P.C. Huijgens (VUMC)


Statistician(s)

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


Principal investigator

E. Vellenga (E.Vellenga@int.azg.nl)


Coordinating investigator(s)

W.E. Fibbe (fibbe.hematology@lumc.nl)
P.C. Huijgens (pc.huijgens@azvu.nl)


Trial manager

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


Central data management

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


Other functions

Statistician:
W.N. van Wieringen(w.vanwieringen@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Leuven-UZ Gasthuisberg
0
NL-Amersfoort-Meander MC
9
NL-Amsterdam-AMC
18
NL-Amsterdam-Antoni van Leeuwenhoek ZH
7
NL-Amsterdam-OLVG
6
NL-Amsterdam-Slotervaart Ziekenhuis
1
NL-Amsterdam-VUMC
36
NL-Delft-Reinier de Graaf Gasthuis
0
NL-Den Haag-Bronovo ziekenhuis
1
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
15
Show 15 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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