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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 75 MCL


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


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News


HO75 news

Sending in of material translational studies

As of today material for translational studies (MRD (only PCR-DNA) and proteomics) can be send to the department of Immunology of the Erasmus MC.

Please use one form per sample to indicate which sample is send in (form can be found on this website).

 

Protocol

A new version of the protocol is available, version 4 (09SEP2010).

Protocol has been amended for the following reasons:

  • increase of patients to include
  • deletion of namecode
  • update of risk section 
  • update of safety section 

 

CRFs

A new version (v7) of the CRFs (and instructions) is available.

(Namecode has been deleted from header)

 

Drug order form

A new version of initial (v2) and re-supply (v3) form is available, this also accounts for the pharmacy info letter (v4).

Changes have been made to contact persons at Janssen Pharmaceuticals and the possibility of ordering per mail has been added.

 


1. Overview



Summary

Bortezomib maintenance therapy in newly diagnosed patients with mantle cell lymphoma, responsive on rituximab combined with CHOP and high dose Ara-C and after BEAM with auto PSCT rescue.


Status

closed



Study details



Type of study

Prospective Phase II study


Type of monitoring for this study

Study specific


Target number of patients

135


Current number of patients

132


Date of activation

01-Mar-2007


Date closed

01-Mar-2012


Approved by

CKTO 2006-07; July 12, 2006
METC Erasmus MC 2006-086; September 14, 2006


Change history / amendement

PRO Version 2 (AM 1); approved METC Erasmus MC 18 December 2008
PRO Version 3 (AM 2); approved METC Erasmus MC 21 January 2009
Amendment 5: PRO Version 4; approved METC Erasmus MC 27 October 2010


Study objectives

Primary objective:
To study the efficacy and toxicity of bortezomib maintenance after induction with HD Ara-C and stem cell transplantation.
Secondary objective:
To study the value of FDG-PET, flow cytomtery and IGVH-PCR for defining the quality of remission after induction with high dose chemotherapy and Rituximab, after auto PSCT and during maintenance treatment with bortezomib, in comparison to conventional definitions


2. Patient eligibility criteria



Inclusion criteria

Inclusion criteria for registration
Patients with histologically and immunologically proven diagnosis of MCL (WHO classification)
Ann Arbor stage II - IV
CD20 positive
Age 18 - 65 years (inclusive)
WHO performance =< 2
Measurable disease (also patients with isolated bone marrow disease are accepted) (appendix B)
Written informed consent

Inclusion criteria for late randomization
Completed BEAM treatment
No progressive disease or relapse
Neutrophils > 0.5 x 10^9/l
Platelets > 80 x 10^9/l


Exclusion criteria

Exclusion criteria for registration
Renal failure (creatinine clearance < 50 ml/min)
Known hypersensitivity to murine antibodies, boron or mannitol
Any other organ dysfunction or failure that may present a risk to the patient during any phase of protocol treatment
Presence of CNS involvement by NHL
Known HIV and hepatitis B or C seropositivity
Pregnancy or lactation
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
Other active malgnancy (less than 5 years in complete remission) except skin (non-melanoma) or cervix carcinoma stage 1
Active systemic infection requiring treatment
Peripheral neuropathy or neuropathic pain Grade 2 or higher as definedby NCI CTCAE version 3
Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study

Exclusion criteria for late randomization:
Known hypersensitivity to murine antibodies, boron or mannitol
Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study


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)
Dhr. Dr. M.B. van 't Veer (Erasmus MC - Daniel)


Statistician(s)

Mw. Dr.ir D. Chitu (Erasmus MC - Daniel)
Dr. W. Ghidey Alemayehu (Erasmus MC - Daniel)


Trial Manager(s)

Mw. A.C. Gussinklo (Erasmus MC - Daniel)


Monitor - Study Specific

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. L. Sitniakowsky (Erasmus MC - Daniel)
Dhr. T. Volker (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - Dhr. Dr. E.F.I. Comans (VUMC)
Reviewer - Imaging - Mw. C. Karga (VUMC)
Reviewer - Pathology - Mw. Dr. D. de Jong (VUMC)
Reviewer - Pathology - Dhr. Dr. R.E. Kibbelaar (Lab. voor de volksgezondheid Friesland)


Principal investigator

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


Statistician(s)

W. Ghideyalemayehu (w.ghideyalemayehu@erasmusmc.nl)


Trial manager

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


Central data management

T. Gussinklo (a.gussinklo@erasmusmc.nl
H. Hofwegen (h.hofwegen@erasmusmc.nl)


5. Participating sites



Site
Included patients *
NL-Amersfoort-Meander MC
0
NL-Amsterdam-AMC
12
NL-Amsterdam-VUMC
16
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
12
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
6
NL-Enschede-Medisch Spectrum Twente
5
NL-Groningen-UMCG
12
NL-Leeuwarden-MC Leeuwarden Zuid
3
NL-Maastricht-AZ Maastricht
4
NL-Nieuwegein-Antonius Ziekenhuis
5
Show 6 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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