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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 117 ALL


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


HO117 news

21 December 2018 - Overall closure of recruitment

27 January 2016 -Recruitment to the trial is suspended


1. Overview



Summary

A phase 2 study for older adults with Acute Lymphoblastic Leukaemia


Status

on hold


Members

University College London in association with HOVON


Validity

Clinicaltrials.gov no: NCT01616238



Study details



Type of study

Prospective Phase II study


Type of monitoring for this study

Site evaluation visits


Target number of patients

150


Current number of patients

0


Approved by

cEC UK
cEC METC (NL)


Study objectives

• Complete remission rate after 2 phases of induction
• EFS at 1 year
• Treatment related mortality
• Complete remission rate after 1 phase of induction
• Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
• Overall Survival at 1 year
• Tolerability of treatment as determined by occurrence of key adverse effects
• Duration of in-patient hospitalisation
• Relationship between performance status/co-morbidity and treatment option chosen
• Quality of life aspects assessed at diagnosis/baseline at various time points.


2. Patient eligibility criteria



Inclusion criteria

• Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
• Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before study registration)
• Written informed consent


Exclusion criteria

• Known HIV infection
• Blast transformation of CML
• Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24;q32) and variant c-myc translocations e.g. t(2;8)(p12;q24), t(8;22)(q24;q11)
• Women who are pregnant or lactating


3. Registration (& randomization) of patients



Registration

At UCL CTC
Fax.nr. +44 20 7679 9861


Registration criteria

The following information will be requested:



Following pre-treatment evaluations (as detailed in section 5.1), confirmation of eligibility and consent of a patient at a site, the registration form must be fully completed and then faxed to UCL CTC. The faxed registration form will be used to confirm patient eligibility at UCL CTC.
A study number and confirmation of treatment allocation will be assigned for the patient and details added to the form.


4. Participating parties



Principal Investigator(s)

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


Principal investigator

dr. A. Fielding (UCL)
mw.Dr. A.W. Rijneveld (HOVON)


Trial manager

E. Marwood - UKALL60+ Trial Coordinator (UCL)
I. Meulendijks (HDC)


Central data management

UCL CTC


Other functions

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



Site
Included patients *
NL-Rotterdam-Erasmus MC
0

* 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




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