CONSENT FORM
RECIPENT SCREENING CONSENT
H-22994- MOST CLOSELY HLA MATCHED ALLOGENEIC VIRUS SPECIFIC
CYTOTOXIC T-LYMPHOCYTES (CTL) TO TREAT PERSISTENT REACTIVATION OR
INFECTION WITH ADENOVIRUS, CMV AND EBV AFTER HEMOPOIETIC STEM CELL
TRANSPLANTATION (HSCT)
Background
You are invited to take part in a research study. Please read this information and feel
free to ask any questions before you agree to take part in the study. In this consent "you"
refers to you or your child.
You have a type of blood cell cancer, other blood disease or a genetic disease for which
you have received a stem cell transplant. After transplant while the immune system
grows back you are at risk of infection. You have had an infection with one or more of
three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) or adenovirus – that
has persisted or recurred despite standard therapy.
Adenovirus is a virus that just causes symptoms of a common cold normally but which
can cause serious life-threatening infections in patients who have weak immune systems.
It usually affects the lungs and can cause a very serious pneumonia, but it can affect the
gut, the liver, the pancreas and the eyes.
CMV is a virus that can also cause serious infections in patients with suppressed
immune systems. It usually affects the lungs and can cause a very serious pneumonia,
but it can also affect the intestinal tract, the liver and the eyes. Approximately two-thirds
(2/3) of normal people harbor this virus in their body. In healthy people CMV rarely
causes any problems because the immune system can keep it under control. If you
and/or your donor are positive for CMV, you are at risk of developing CMV disease while
your immune system is weak post transplant.
EBV is the virus that causes glandular fever or kissing disease. It is also normally
controlled by a healthy immune system but when the immune system is weak can cause
fevers, enlarged lymph nodes and some times develop into a type of cancer called
lymphoma.
We are therefore asking if you would like to participate in this study which tests if blood
cells from a donor that is a partial match with you and your transplant donor and that
have been grown in a special way, can help treat infections with these viruses.
This treatment with specially trained T cells (called CTLs) has had activity against these
viruses when the cells are made from the transplant donor. However as it takes tow to
three (2-3) months to make the cells that approach is not practical when you already
have an infection. We want to find out if we can use CTLs that we have already made
from another donor who matches as closely as possible and if they will last in your body
and have activity against these viruses. These cells are called “trivirus specific CTLs”
because they can attack all three (3) viruses.
We would like to search this bank to see if there is a CTL line that is a match with you.
This research study is funded by NIH/NHLBI.
Purpose
The purpose of this study is to find if there are trivirus specific CTLs from a donor in the
bank that match you closely enough.
Procedures
A total of 45 subjects at eight (8) institutions will be asked to participate in this study. You
will be one of approximately 30 subjects to be asked to participate at this location.
We feel that it is important for you to know how many people we plan to enroll on this
study.
The research will be conducted at the following location(s): Baylor College of Medicine,
TCH: Texas Children's Hospital, UT: MD Anderson Cancer Center.
If you wish to consider this study your doctor will first look in a database to see if there is
a CTL line that is a close match with you and your donor using your HLA type which
measures 6 proteins on the surface of your cells. These CTL lines have been made at
Baylor College of Medicine from donors for other transplant patients or other normal
donors. All donors have been screened in the same way that we screen blood donors.
When the CTL lines were made blood was taken from the donors and used to grow T
cells. To do this we first infected blood cells called monocytes with a specially produced
adenovirus gene that also carries part of the CMV gene. These monocytes with these
new genes then stimulated the T cells. This stimulation trained the T cells to kill cells
with this part of the CMV virus or with adenovirus. We then grew these CTLs with more
stimulation with EBV infected cells (which we made from donor blood by infecting them
with EBV in the laboratory). We also put the adenovirus that carries the CMV gene into
these EBV infected cells so that they too had CMV and adenovirus proteins. These EBV
infected cells were treated with radiation so they cannot grow. By this type of culture we
grew out T cells that can see and attack cells infected with EBV, adenovirus or
CMV. Once we made sufficient numbers of T cells we tested them to make sure they
killed cells infected with these viruses and froze them.
If there is a line with enough matching your doctor will discuss if you want to participate
in the study and receive this CTL line. You will sign a separate consent at this stage.
If there is no line that matches you we would like to follow you to find out whether the
standard treatment you receive works or not. Your transplant center will provide data on
whether your infection gets better with other treatment.
You can see and get a copy of your research related health information. Your research
doctor may be able to provide you with part of your information while the study is in
progress and the rest of your information at the end of the study.
As this portion of the study involves screening and data collection the only risk is a
minimal risk of loss of confidentiality. We will minimize this by storing information in
password protected databases.
Study staff will update you in a timely way on any new information that may affect your
decision to stay in the study.
Potential Benefits
The benefits of participating in this study may be: that you may be able to receive CTLs
on this study.
However, you may receive no benefit from participating.
Alternatives
The following alternative procedures or treatments are available if you choose not to
participate in this study: You can receive standard therapy with Ganciclovir, Foscarnet,
or Cidofovir if you have a CMV infection, Rituximab if you have EBV or Cidofovir if you
have adenovirus. Additionally, the same alternatives are available during participation in
this research project.
Subject Costs and Payments
You will not be asked to pay any costs related to this research.
You will not be paid for taking part in this study.
Research Related Injury
You will get medical treatment if you are injured as a result of taking part in this study.
The study will not pay for medical treatment. Research personnel will try to reduce,
control, and treat any complications from this research. If you are injured because of this
study, you will receive medical care that you or your insurance will have to pay for just
like any other medical care.
Subject's Rights
Your signature on this consent form means that you have received the information about
this study and that you agree to volunteer for this research study.
You will be given a copy of this signed form to keep. You are not giving up any of your
rights by signing this form. Even after you have signed this form, you may change your
mind at any time. Please contact the study staff if you decide to stop taking part in this
study. If you choose not to take part in the research or if you decide to stop taking part
later, your benefits and services will stay the same as before this study was discussed
with you. You will not lose these benefits, services, or rights.
Your Health Information
We may be collecting health information that could be linked to you (protected health
information). This protected health information might have your name, address, social
security number or something else that identifies you attached to it. Federal law wants
us to get your permission to use your protected health information for this study. Your
signature on this form means that you give us permission to use your protected health
information for this research study. If you decide to take part in the study, your protected
health information will not be given out except as allowed by law or as described in this
form. Everyone working with your protected health information will work to keep this
information private. The results of the data from the study may be published.
However, you will not be identified by name. People who give medical care and ensure
quality from the institutions where the research is being done, the sponsor(s) listed in the
sections above, representatives of the sponsor, and regulatory agencies such as the U.S.
Department of Health and Human Services will be allowed to look at sections of your
medical and research records related to this study. Because of the need for the
investigator and study staff to release information to these parties, complete privacy
cannot be guaranteed. The people listed above will be able to access your information
for as long as they need to, even after the study is completed.
If you decide to stop taking part in the study or if you are removed from the study, you
may decide that you no longer allow protected health information that identifies you to be
used in this research study.
Contact the study staff to tell them of this decision, and they will give you an address so
that you can inform the investigator in writing. The investigator will honor your decision
unless not being able to use your identifiable health information would affect the safety
or quality of the research study.
The investigator, HELEN E. HESLOP, and/or someone he/she appoints in his/her place
will try to answer all of your questions. If you have questions or concerns at any time, or
if you need to report an injury related to the research, you may speak with a member of
the study staff: HELEN E. HESLOP at (832) 824-4662 during the day and after hours.
Members of the Institutional Review Board for Baylor College of Medicine and Affiliated
Hospitals (IRB) can also answer your questions and concerns about your rights as a
research subject. The IRB office number is (713) 798-6970. Call the IRB office if you
would like to speak to a person independent of the investigator and research staff for
complaints about the research, if you cannot reach the research staff, or if you wish to
talk to someone other than the research staff.
If your child is the one invited to take part in this study you are signing to give your
permission. Each child may agree to take part in a study at his or her own level of
understanding. When you sign this you also note that your child understands and agrees
to take part in this study according to his or her understanding.
Please print your child's name here ___________________________________
Signing this consent form indicates that you have read this consent form (or have had it
read to you), that your questions have been answered to your satisfaction, and that you
voluntarily agree to participate in this research study. You will receive a copy of this
signed consent form.
Subject
Date
Legally Authorized Representative
Parent or Guardian
Date
Investigator or Designee Obtaining Consent
Date
Witness (if applicable)
Translator (if applicable)
Date