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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 900 DLBCL screening


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


HOVON 900 DLBCL status

 

The HOVON 900 DLBCL study has been decoupled from the HOVON 130 study.

 

The HOVON 130 is nearly completed inclusion. Because of this the HOVON 900 study documents have been updated and no longer suggest HOVON 130 treatment. In addition:

• WHO 2016 criteria have been implemented, replace the WHO 2008 criteria.

• Eligibility criteria have been updated to exclude transformed lymphoma from HOVON 900 registration

 

 

Updated documents

 

    08-FEB-2018 - protocol amendment implemented

 • HO900 DLBCL screening pro v4 08-FEB-2018_signed replaces replaces the previous version HO900 DLBCL screening pro v3 11-DEC-2015_signed

• HO900 ICF v4 08-FEB-2018 replaces replaces the previous version HO900 ICF v 3 22 juni 2015

 

    18-DEC-2015 - protocol amendment implemented

• HO900 DLBCL screening pro v3 11-DEC-2015_signed replaces the previous version ho900-dlbcl-screening-pro-v2-21062015.pdf

• HO900 protocol summary of changes 11-DEC-2015 replaces previous version ho900-dlbcl-screening-pro-v2-21062015.pdf

 

 


1. Overview



Summary

Patients over 18 years with DLBCL (according to WHO 2016 classification) with a proven MYC rearrangement as detected by FISH, are high risk patients and have a very poor prognosis on standard first line therapy with R-CHOP immune-chemotherapy. To identify MYC rearranged DLBCL patients, all DLBCL patients will (after informed consent) be registered in this screening-database (HOVON 900). Subsequently, MYC FISH testing will be performed and patients with a proven MYC rearrangement will be considered for other treatment than R-CHOP (either according to an open trial or according to the HOVON Lymphoma Working Group guidelines in case no trials are open or in case the patient is not eligible). All patients (treated in trials as well as patients treated outside trials) will be included in a virtual tissue bank (HOVON Pathology Facility and Biobank (HOP)) for future tissue-based MYC-related studies and for epidemiological studies.

All logistics will be performed by the HOVON Pathology Facility and Biobank (HOP, hop@vumc.nl).


Status

open


Members

HOVON



Study details



Type of monitoring for this study

None


Target number of patients

2000


Current number of patients

1059


Study objectives

The primary objective is to effectively identify patients who may be eligible for the HOVON130 trial, to collect anonymized data of all DLBCL and BCL-U patients (MYC positive and negative) for epidemiological studies and to install a virtual tissue bank for future comparative MYC-related biological research.


2. Patient eligibility criteria



Inclusion criteria

♦ All patients diagnosed with newly diagnosed DLBCL according to WHO 2016. (patients with transformed follicular lymphoma are not eligible)
♦ Age ≥ 18 years
♦ Within 8 weeks after the diagnosis of DLBCL


3. Registration (& randomization) of patients



Registration

Eligible patients should be registered. Patients need to be registered at the HOVON Data Center by one of the following options:
Trial Online Process (TOP, https://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.
By faxing the completed registration/randomization CRF +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET
By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00 CET


Registration criteria

The following information will be requested:



• Protocol number
• Institution name
• Name of caller/responsible investigator
• Local patient code (optional)
• Sex
• Date of birth (or partial date of birth if date of birth not allowed, e.g.01/01/YOB)
• Date written informed consent
• Specific items for which this patient gives consent (see ICF)
• Date of diagnosis
• Diagnosis (DLBCL or BCL-U)
• Name of the local pathology laboratory
• Local pathology registration number


4. Participating parties



Principal Investigator(s)

Dr. M. Chamuleau (VUMC)


Trial Manager(s)

Mw. J. Refos (Erasmus MC - Daniel)


Central Data Manager(s)

Dhr. Drs. R. Sewsaran (Erasmus MC - Daniel)


Other functions

Reviewer - Pathology - HOP pathologist (VUMC)
Reviewer - Pathology - Mw. Dr. D. de Jong (VUMC)
Reviewer - Pathology - Drs. M. Nijland (UMCG)


Trial manager

H. Zanders ( w.zanders@erasmusmc.nl )
N.G.J.H. Lamers ( n.lamers@erasmusmc.nl )


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
NL-Alkmaar-MC Alkmaar
0
NL-Almelo-Ziekenhuisgroep Twente, loc. Almelo
18
NL-Amersfoort-Meander MC
23
NL-Amsterdam-Antoni van Leeuwenhoek ZH
9
NL-Amsterdam-OLVG
12
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
0
NL-Amsterdam-VUMC
13
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
3
NL-Assen-Wilhelmina Ziekenhuis
7
NL-Beverwijk-Rode Kruis Ziekenhuis
15
Show 56 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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