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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 55 MCL


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


HO55 news

This study has been closed on 21 October 2010.


1. Overview



Summary

Efficacy of maintenance therapy with rituximab after induction chemotherapy (R-CHOP vs. R-FC) for elderly patients with mantle cell lymphoma not suitable for autologous stem cell transplantation


Status

closed


Members

Participating Groups: CLSG, GELA, GLSG, HOVON and Nordic Lymphoma Group



Type of study

Prospective randomized Phase III study


Target number of patients

570


Current number of patients

95


Date of activation

10-Jan-2005


Date closed

21-Oct-2010


Approved by

CKTO: CKTO 2004-03, 12 November 2004
MEC: METC Erasmus MC, 15 December 2004


Study objectives

To test in elderly patients with advanced mantle cell lymphoma, whether rituximab plus a combination of fludarabine with cyclophosphamide (6 FC cycles) results in a higher reduction of lymphoma mass measured by the percentage of CR than rituximab combined with the standard chemotherapy scheme (8 CHOPcycles).
To compare maintenance therapy with rituximab with maintenance with interferon-alpha or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with mantle cell lymphoma.


2. Patient eligibility criteria



Inclusion criteria

Histologically proven mantle cell lymphoma according to the WHO classification, preferably confirmed by central pathology review beforehand
Clinical stage II, III or IV
Previously untreated patients
Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
WHO performance <= 2
Informed consent according to ICH/EU GCP and national/local regulations
Measurable disease. If e.g. only BM infiltration, patients can only undergo a second randomization if a CR is obtained


Exclusion criteria

WHO performance of 3 or more
Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
Leukocytes <2.0x 10^9/l or thrombocytes <100x 10^9/l, unless clearly related to MCL bone marrow infiltration
Patients previously treated for lymphoma
Patients without measurable lesions; if e.g. only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of CR
Patients with stage I disease
Patients with central nervous system involvement
Patients with a history of autoimmune hemolytic anaemia or autoimmune trombocytopenia
Patients with serious cardiac disease (uncontrolled arrhythmias, unstable angina,severe congestive heart failure)
Patients with serious pulmonary, neurological, endocrinological or other disorder interfering with full dosing of CHOP or FC chemotherapy
Liver enzymes >3x normal or bilirubin >2.5x normal (not due to lymphoma)
Creatinine >2x normal value, corrected for age and weight (not due to lymphoma)
Patients with unresolved hepatitis B or C infection or HIV positive infection
Uncontrolled infection
Patients with a serious depression that needed therapy within the last 5 years
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years


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 (optional)
Sex
Date of birth
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Mw. Dr. J.K. Doorduijn (Erasmus MC - Daniel)
Prof. Dr. J.C. Kluin-Nelemans (UMCG)
Dhr. Dr. M.B. van 't Veer (Erasmus MC - Daniel)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Mw. M. Vania (Erasmus MC - Daniel)


Principal investigator

Prof.Dr. J.C. Kluin-Nelemans (j.c.kluin@int.umcg.nl)


Coordinating investigator(s)

Dr. J.K. Doorduijn (j.doorduijn@erasmusmc.nl)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

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


5. Participating sites



Site
Included patients *
NL-Alkmaar-MC Alkmaar
1
NL-Amersfoort-Meander MC
0
NL-Amsterdam-AMC
4
NL-Amsterdam-Antoni van Leeuwenhoek ZH
4
NL-Amsterdam-OLVG
2
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
0
NL-Amsterdam-VUMC
9
NL-Beverwijk-Rode Kruis Ziekenhuis
0
NL-Breda-Amphia ziekenhuis, locatie Langendijk
3
NL-Delft-Reinier de Graaf Gasthuis
6
Show 20 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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