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Clinical picture: ALL (Acute Lymphatic Leukemia)

Trial: HOVON 117 ALL


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


HO117 news

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



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 - Centrum)


Trial Manager(s)

Mw. I. Meulendijks (Erasmus MC - Daniel)


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


5. Participating sites



Site
Included patients *
NL-Rotterdam-Erasmus MC - Centrum
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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