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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 100 ALL / EORTC


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


HO100 news

 

 

24JAN2017 The reporting of Safety forms in the HO100 study has changed. From now one you must send to new faxnumber +31(0)10 7031201. See also adjusted SAE form /pregnancy form.
07NOV2016: HOVON 100 study closed for further patient inclusion 

The HOVON 100 ALL/EORTC 06083 trial is closed as of 07-NOV-2016 for the inclusion of new patients. The trial is closed because it has reached its target of 376 patients.

 

The patients that were included should be treated and followed according to protocol. We kindly ask you to send in send in the treatment data and Follow Up data per CRF to the HOVON Data Center. Also remember to send in the data/material for the side studies and central reviewers.

 

We would like to thank you for your enthusiasm. Only with your participation were we able to reach this milestone.

 

 

07SEPT2016:HOVON100 patient screening list” for the last HO100 patients

Important: “HOVON100 patient screening list” for the last HO100 patients
If you have a patient in screening for the HO100 study, please inform HDC
Your patient will be added to the “HOVON100 patient screening list” and we will inform you about how many patients at that moment are in screening.
 Please provide in this email:
1.       the date of birth
2.       the planned date when expected to register the patient in the HO100
3.       the planned start date for the first HO100 cycle.
 
Only patients listed on the “HO100 patient screening list” who are eligible will actually be registered by us.
Because there are 30 sites open for inclusion, no registration places can be reserved. If the list of patients in screening becomes longer than  patients that can still be registered no more patients will be listed on the screening list.
 
Important: Please inform us as soon as possible if the (your) patient listed on the screening list turns out not to be eligible during screening for the HO100, so we can delete the listed patient from the “HOVON100 patient screening list”.
 
Important: Registration the last HO10O patients via TOP
Patient registration in TOP will be exclusively done via the HOVON Data Center (HDC).
Participating sites can no longer register a patient in TOP.
For registering a patient you must complete the HOVON100 MM registration form and fax it to the HOVON Data Center.
Note: Only patients listed in “HOVON100 patient screening list” who are eligible will actually be registered by us.
08AUG2016: Gewijzigde medicatie bestelformulieren en Pharmacy Info letter

Er zijn vanaf heden 8 AUGUSTUS enkele  wijzigingen in de bestel procedures van de HO100 medicatie; Clofarabine en PEG-Asparaginase (Oncaspar)

HO1O0 Clofarabine medicatie:Het e-mail adres is gewijzigd voor het bestellen van clofarabine ; de bestelformulieren moeten gemailed worden naar CTSRequests-TGR@pciservices.com

HO100 PEG-Asparaginase (Oncaspar)

De bestelformulieren van PEG-Asparaginase (Oncaspar) zijn gewijzigd (Komtur Pharmaceuticals Berlin)

Het  e-mail adres is gewijzigd voor het bestellen van medicatie; de PEG-Asparaginase bestelformulieren moeten gemailed worden  naar oncaspar@komtur.com

De artsenverklaring moet nog bij elke bestelling meegestuurd worden.

 

 

07APR2015: SKION Netherlands new address: Zinkwerf 5-7, 2544 EC THE HAGUE. From 15 April 2015, send MRD samples to the new address
07APR2015:  lab Investigations NL and MRD logistics NL has been updated  

28OCT2014: Info Pharmacy letter and order form PEG-L-asparaginase has been updated

10JUN2014: Amendment 13 (for Dutch and Belgian sites only); protocol version 27-MAR-2014 valid

05JUL2012: Current phase: III; Current dose level clofarabine: 30 mg/m2

 


1. Overview



Summary

Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults


Status

open


Members

Participating groups: HOVON, EORTC



Type of study

Prospective Phase II/III study


Echelon level

Level C-SCT


Echelon level specification

For AlloSCT, arrangement with level A hospital is required.


Type of monitoring for this study

Site evaluation visits


Target number of patients

376


Current number of patients

373


Date of activation

22-Oct-2009


Approved by

Approved for NL by MEC Erasmus MC 31 AUG 2009

Approved for B by MEC UZ Leuven 30 JUN 2010

Approved for F by CCP Ile de France II 17 OCT 2011


Change history / amendement

AM6 implemented for NL, B and F at 09 DEC 2011
AM8 implemented for NL at 15 JUN 2012
AM13 implemented for NL and B at 10 JUN 2014


Study objectives

Phase II: To determine the feasibility of i.v. clofarabine given prior to standard induction chemotherapy as part of pre-phase

Phase III: To improve event free survival by adding i.v. clofarabine to prephase and consolidation therapy


2. Patient eligibility criteria



Inclusion criteria

Patients aged 18 to 70 years inclusive
Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL (pretreatment with prednisolone for 7 days is allowed)
WHO performance status 0 – 2
Adequate renal and hepatic function tests as indicated by the following laboratory values:
Serum creatinine ≤1.0 mg/dl (≤ 88.7 micromol/L); if serum creatinine >1.0 mg/dl (>88.7 micromol/L), then the glomerular filtration rate (GFR) must be >60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dl)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black)
NOTE: if serum creatinine is measured in micromol/L, recalculate it in mg/dl according to the equation: 1 mg/dl = 88.7 micromol/L) and use above mentioned formula.
Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN
Alkaline phosphatase ≤ 2.5 × ULN
Negative pregnancy test at inclusion, if applicable
Written informed consent


Exclusion criteria

Mature surface Ig positive B-cell leukemia/lymphoma
Acute undifferentiated leukemia
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
Severe neurological or psychiatric disease
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
Active, uncontrolled infection
Patient known to be HIV-positive
Patient is a lactating woman
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 yrs for at least one year)


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
Name of responsible physician
Patient name code
Date of birth
Sex
Date of informed consent
Patient consent for storing body material, approach for future studies, using collected data for future studies
Eligibility criteria
Immunophenotype ALL


4. Participating parties



Principal Investigator(s)

Mw.Dr. A.W. Rijneveld (Erasmus MC - Centrum)


Co-Investigator(s)

Prof. Dr. J.J. Cornelissen (Erasmus MC - Daniel)
Dhr. Dr. S.M.G.J. Daenen (UMCG)


Coordinating Investigator(s)

Prof. dr. J.A. Maertens (UZ Gasthuisberg)
Prof. dr. J.P. Marie (St. Antoine Hospital)


Statistician(s)

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


Trial Manager(s)

Dhr. N. Lamers (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. S. Jägers (Erasmus MC - Daniel)
Mw. W.M Keller (Erasmus MC - Daniel)


Other functions

Central Coordinator - MRD - Mrs. Dr. M. Bakkus (Universitair Ziekenhuis Brussel)
Central Coordinator - MRD - Mw. V. de Haas (Stichting Kinderoncologie Nederland)
Central Coordinator - MRD - Mw.Dr. A.W. Rijneveld (Erasmus MC - Centrum)
Central Coordinator - MRD - Dhr. E. Sonneveld (Stichting Kinderoncologie Nederland)
Central Coordinator - MRD - Mw. J. Van der Straeten (Universitair Ziekenhuis Brussel)
Central Coordinator - MRD - Mw. K. Vannerom (Universitair Ziekenhuis Brussel)
Central Coordinator - Special Investigations - Mw. M. Spiering (AMC)
Reviewer - Cytogenetics - Mw. Dr. H.B. Beverloo (Erasmus MC - Medische Faculteit)
Reviewer - HRC - HRC (Erasmus MC - Daniel)


Principal investigator

dr. A. W. Rijneveld


Trial manager

J. Refos (j.refos@erasmusmc.nl)


Central data management

Sjef van Asten (j.vanasten@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Middelheim
1
BE-Antwerpen-ZNA Stuivenberg
6
BE-Antwerpen Edegem-Universitair Ziekenhuis Antwerpen
7
BE-Brugge-Algemeen Ziekenhuis St. Jan
19
BE-Brussel-Institut Jules Bordet
0
BE-Bruxelles-Cliniques Universitaires St. Luc
12
BE-Charleroi-CHU de Charleroi-Civil
0
BE-Gent-UZ Gent
2
BE-Leuven-UZ Gasthuisberg
1
BE-Liege-Hopital de la Citadelle
4
Show 21 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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