AML 17 TRIAL: PATIENT INFORMATION SHEET 7
(Ref. ISRCTN55675535)
Consolidation: One versus Two Courses
Of High Dose Ara-C
Introduction:
You have now completed 2 courses of treatment and your marrow remains
in complete remission. This information sheet explains the final
chemotherapy comparison we want to make in this trial.
What is the purpose of this randomisation?
You have had 2 courses of treatment. Your doctor considers you to be
sufficiently recovered to receive the next part of your chemotherapy plan.
In the past, for patients at this stage, we have tested whether another
three courses had an advantage over another two courses. We found that
the extra course did not improve the long term response for patients. We
have some evidence that patients may do just as well with only one more
course rather than two courses at this point, but we do not have enough
information to be sure. So the aim of this part of the trial is to compare the
effect of giving one or two more courses of chemotherapy. Patients are
selected into each group in a randomised way to ensure equal spread of
age and gender differences.
The schedule known as high dose Ara-C which has been used for many
years in standard treatment, will be used. Patients allocated to receive a
second course, will receive the same treatment approximately 4 to 6
weeks later. Each course of treatment lasts for a maximum of 5 days and
has very similar effects as the treatment you have already had.
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Although similar to the treatment that you already have had, these
treatments usually result in your marrow taking a few days longer to
recover, so that you will be in hospital for the treatment, and you will be
followed closely after each course. It is likely that you will require red cell
and platelet transfusion until you counts recover about four weeks after the
treatment has finished, and that you will require antibiotic treatment for
infection. In about 10% of patients the recovery of counts can take several
weeks requiring continuous transfusion support.
What will happen?
If you agree you will be randomised to receive one or two further courses.
However if you do not enter the two versus one randomisation you will be
allocated to receive two courses because that is considered the current
standard treatment.
The treatment options in this randomisation are one or two courses of
High Dose Ara-C You have a 50% chance of getting either treatment.
Will it have side-effects?
The effects of this course of treatment will be similar to those you
experienced with your previous courses with some further hair loss and
damage to the immune system. The pattern of the fall in your blood count,
the need for transfusion support and the risk of infection requiring strong
antibiotics will now be familiar to you. It is probable that your blood counts
will take a few days longer to recover than they did with your previous
treatments.
Will this treatment benefit me?
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We do not know whether one as opposed to two more courses is
beneficial until the comparison is done. You may or may not benefit more
from the treatment you are allocated to.
Contact for Further Information
Further information can be obtained from your local organiser (Principal
Investigator) or the UK organiser (Chief Investigator) whose addresses are
given below.
Chief Investigator:
Prof Alan Burnett
Department of Haematology
University Hospital of Wales
Cardiff
CF14 4XW
Tel: 029 2074 2375
e-mail: BurnettAK@cardiff.ac.uk
Thank you for your participation in the trials so far and for
considering this last stage of the trial.
Patient Information and Consent form 7,
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Version 5. May 2010
CONSENT FORM 7
FOR
Acute Myeloid Leukaemia 17 Trial
(Trial Reference ISRCTN55675535)
Consolidation: One versus Two Courses
Of High Dose Ara-C
(Please initial)
1.
I have read the attached Information Sheet version 5 dated May 2010
2.
I have had an opportunity to discuss this study and ask questions
3.
I have received satisfactory answers to all of my questions
4.
I have received enough information about the study
5.
I have spoken with Dr./ Mr./Ms.__________________________
6.
I understand that I am free to withdraw from the study:

at any time

without having to give reasons

without affecting my future medical care
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7. I understand that sections of my medical records relating to my participation in
the study may be inspected by responsible individuals from the trial Sponsor
who is Cardiff University. All personal details will be treated as STRICTLY
CONFIDENTIAL. The information will be used for medical research only and I
will be identified only by trial number, initials and date of birth. I will not be
identified in any way in analysis and reporting of the results.
I give permission for these individuals to have access to my records and to
have my clinical details recorded in this way
8.
I agree to participate in this study
9.
I give permission to tell my GP about my participation in the study
Patient’s Signature:_____________________________________
Name in block letters:___________________________________
Date_____________________
Doctor’s Signature:_____________________________________
Name in block letters:___________________________________
Date_____________________
Patient Representative’s Signature:
(if appropriate)_________________________________________
Name in block letters:___________________________________
Relationship to patient: __________________________________
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Date_____________________
Patient Information and Consent form 7,
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Version 5. May 2010