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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 900 DLBCL screening


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


HOVON 900 DLBCL status

  

Updated documents

    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 and BCL-U with a proven MYC rearrangement as detected by FISH, are considered high risk patients with a very poor prognosis after standard first line therapy with R-CHOP immune-chemotherapy. For this patient group, the HOVON130 clinical trial is designed.

The HOVON130 project as supported by the KWF/Alpe d'Huzes program also includes a registration study (HOVON900) to monitor the effectiveness and to support optimal MYC-FISH screening in the Netherlands. In this registration database, all patients with DLBCL / BCL-U are registered, irrespective of MYC status and irrespective of inclusion in the HOVON130 trial.
The registration database will enable effective screening and will be the basis for future comparative epidemiological and biological studies. Informed consent is required for inclusion in the registration database and for possible future retrieval of samples. All logistics will be performed by the HOVON Pathology Facility and Biobank (HOP, hop@vumc.nl).


Status

open


Members

HOVON



Type of monitoring for this study

None


Target number of patients

2000


Current number of patients

661


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 or BCL-U according to WHO 2008
• Age ≥ 18 years
• Within 8 weeks after the diagnosis of DLBCL or BCL-U


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)

Mw. Dr. M. Chamuleau (VUMC)


Trial Manager(s)

Mw. J. Refos (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

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


5. Participating sites



Site
Included patients *
NL-Alkmaar-MC Alkmaar
0
NL-Almelo-Ziekenhuisgroep Twente, loc. Almelo
9
NL-Amersfoort-Meander MC
17
NL-Amsterdam-Antoni van Leeuwenhoek ZH
9
NL-Amsterdam-OLVG
11
NL-Amsterdam-Sint Lucas Andreas ZH, Lucas
0
NL-Amsterdam-VUMC
10
NL-Apeldoorn-Gelre ziekenhuizen, Apeldoorn
2
NL-Assen-Wilhelmina Ziekenhuis
7
NL-Beverwijk-Rode Kruis Ziekenhuis
8
Show 53 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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