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Leukaemia working group


1. Trials
2. Developments
3. Trial analyses
4. HOVON-SAKK Minutes

 


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1. Trials

 
For the various forms of leukaemia that fall within the responsibility of the working group,a backbone of trials is formulated that must more or less always be activated. Trial-free periods are avoided as far as possible. In addition, trials can be proposed which can be implemented on the basis of prioritisation, in collaboration and consultation with the other working groups and the HOVON board. The fixed core of trials consists of:

AML: randomised trial < 60 years
Phase II trial(s) > 60 years

ALL: (randomised ) trial <60 years

CML: randomised trial <60years

MDS: randomised trial at low risk MDS

Currently work is also underway on:

Maintenance requirement for AML: allogeneic stem cell transplantation with reduced conditioning in collaboration with SCT working group / azacytidine for the control group;
CML trial amongst the elderly.

 

Please find below an overview of non-HOVON trials (phase 1/2) that are open in the Netherlands

Overzicht fase 1/2 studies

 

 


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2. Developments

 
The working group is investing heavily in the systematic linking of laboratory studies to clinical trials, with a view to deriving clinically-relevant biological, molecular, pharmakinetic and immunological information from therapy studies. The success of these efforts is to a considerable extent determined by the efficiency of the sample collection, in terms of quality and quantity. The objective is both a high yield in participation from the centres, and achieving a high output from sampling. The quality, standardisation and quality control of the determinations will also be a permanent point for attention. Interactions with the molecular working group MODHEM are of course of immediate importance;
Currently, intensive investment is underway aimed at running MRD measurement on the basis of multicolour flow cytometry, gene mutation analysis and genetic profiling by gene expression arrays alongside the trial, on a routine basis. This will generate important experience and will perhaps also result in a model for ensuring that other side studies linked to clinical trials can also run smoothly. It is expected that in the future any genome-wide approaches will be implemented for evaluation in the clinical approach;
MRD determinations will also be incorporated in the ALL trials;
The working group intends to operate in an international perspective and aims to establish trials that will in particular prove attractive to foreign centres. Expansion of participation by foreign partners will increase the influx of patient numbers in trials, and hence increase the effectiveness of HOVON as a study group. This is perhaps even more important than in the past for HOVON, with a view to remaining a leading player as a competitive group: good, feasible studies with short lead times;
A model is being developed for Phase II trials that offers possibilities for running multiple trials simultaneously, the advantage being that all that is required for a new trial is an amendment, thus offering the possibility of launching concept Phase III trials via a 'pick a winner', once a promising new strategy is identified in the Phase II trials. In this way, HOVON will also become an attractive partner for industry as it will be capable of rapidly testing new medicines. This new concept will first be tested with older patients with AML. Subsequently, other tumour working groups could profit;
To be able to rapidly conclude trials, foreign partners will continue to be necessary . Alongside SAKK and Belgian partners, attempts will also be made to achieve collaboration with other foreign leukaemia working groups.

 


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3. Trial analyses

 
The analyses that will have to be implemented in the near future are:

H42;
H43;
H51: This trial has particular priority since (if the good interim results are confirmed with this more definitive analysis), this result can be used as the most important support in improving the disappointing inclusion in the H78.

 


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4. HOVON-SAKK Minutes

 
When logged in, you will be able to see a submenu containing the HOVON-SAKK minutes of the Schiphol meetings.

 


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