Sample Allo CTL Protocol Donor Consent

Allogeneic CTL Study
Donor Treatment Consent
Version 1.00
August 15, 2008
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
In this consent "you" refers to you or your child.
We are asking permission to take blood from you to grow a special type of T cell
that fights viruses that may be given to a patient (recipient) who has had a blood
or bone marrow transplant (BMT) for a type of blood cell cancer, other blood
disease or a genetic disease. You may be being asked to do this because you
have been a bone marrow donor in the past or because you have a common
HLA type that may match many potential patients. As part of this research study,
we are trying to learn if closely matched T cells might help to treat virus infections
in BMT recipients. The T cells that we will make will have activity against three
viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.
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 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
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 plan to grow your T cells in the laboratory in a special way, to see if they 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 two to three (2-3) months to
make the cells that approach is not practical when the recipient already has an
infection. We want to find out if we can use CTLs that we have already made
Allogeneic CTL Study
Donor Treatment Consent
Version 1.00
August 15, 2008
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.
The purpose of this study is to obtain some of your blood to make trivirus specific
CTLs so they would be available to potentially treat a recipient who had an
infection with one of these viruses.
You will be one of approximately (45) subjects to be asked to participate in this
trial. The CTL lines will be made at Baylor College of Medicine and may be given
to patients at several sites who are participating in the clinical trial. If a patient
has an infection with one of the three (3) viruses their doctor will first look in a
database to see if there is a CTL line that is a close match with them using HLA
type which measures six (6) proteins on the surface of cells. If your CTL line is
the best match it may be given to a patient but there is also a possibility your line
may never be the best match and will never be given.
If you agree to be in this study you will first undergo the following evaluations:
1) a medical evaluation, a questionnaire that is given to blood donors.,
and a series of laboratory tests,
2) testing for diseases such as hepatitis and HIV (within seven (7) days of the
blood collection), and
3) if a female of child bearing age, a pregnancy test.
These evaluations will determine if the recipient might experience unexpected
risks from receiving your cells. You have the right to review your record and ask
to change incorrect information. If your medical evaluation discloses any
abnormalities, you will be informed. We may also be required by law to notify
your state public health agency if you test positive for hepatitis B, hepatitis C, HIV
or other infectious diseases.
If this assessment shows that you are a suitable donor, we will draw 40-80 mls of
blood to make the CTL line. To do this we first infect 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 stimulate the T
cells. This stimulation will train the T cells to kill cells with this part of the CMV
virus or with adenovirus. We then grow these CTLs with more stimulation with
EBV infected cells (which we will make from donor blood by infecting them with
EBV in the laboratory). We will also put the adenovirus that carries the CMV
gene into these EBV infected cells so that they too have CMV and adenovirus
proteins. These EBV infected cells will be treated with radiation so they cannot
Allogeneic CTL Study
Donor Treatment Consent
Version 1.00
August 15, 2008
grow. By this type of culture we grow out T cells that can see and attack cells
infected with EBV, adenovirus or CMV. Once we have made sufficient numbers
of T cells we will test them to make sure they kill cells infected with these viruses
and freeze them.
Any left over samples of tissues (blood) or the cell lines may be used to help
research. The specimens may be kept for a long time or given to a third party.
These specimens and information about your circumstances may be shared with
other researchers. Although there will be a record identifying under what
circumstances these specimens were obtained, under all circumstances your
identity will be kept confidential.
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.
Potential Risks
Possible side effects from drawing blood may include pain or bruising at the site
of the needle puncture. There is a very small risk of an infection at the site of the
needle puncture. Also, it is possible that a person may faint when blood is drawn.
Care will be taken to clean the site well and therefore decrease the risk of
infection. Unforeseeable and/or unknown risks/discomforts may occur.
Once the blood sample has been obtained there is no risk to you from the
laboratory work that will be done to the T-cells.
Potential Benefits
You have been told that you will receive no direct benefit from your participation
in this study. However, your participation may help the investigators learn if CTLs
from closely matched donors can treat infections in transplant patients.
You may choose not to participate in this study:
Subject Costs and Payments
You will not be charged for any evaluations that are being done solely as part of
your participation in this research project. You will have an opportunity to discuss
any financial concerns with a financial counselor.
There could be considerable time and effort spent to develop a potential
commercial product which is a significant commitment of resources on the part of
this institution. Therefore, this institution does not plan to pay royalties to you
Allogeneic CTL Study
Donor Treatment Consent
Version 1.00
August 15, 2008
should a commercial product be developed from your blood or tissue as a
consequence of this research.
Subject Rights
Your signature on this consent form means that you have received the
information about this study and that you agree to be a part of the 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.
The investigator or sponsor may decide to stop you from taking part in this study
at any time. You could be removed from the study for reasons related only to you
(for example, if you move to another city, if you do not take your study
medication, or if you have a serious reaction to your study medication) or
because the entire study is stopped. The sponsor may stop the study at any time.
There may be unknown risks/discomforts involved. Study staff will update you in
a timely way on any new information that may affect your health, welfare, or
decision to stay in this study.
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. You will not
be paid for the injury.
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, agents of the Food and Drug Administration, and
regulatory agencies such as the U.S. Department of Health and Human Services
Allogeneic CTL Study
Donor Treatment Consent
Version 1.00
August 15, 2008
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, 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: 832-824-4670 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.
Your signature on this consent form attests to the fact that your child
_______________________________ has, within limits imposed by age,
maturity, and psychological state, given his/her assent (affirmative agreement) to
participate in this research project.
Signature of Recipient
Signature of Investigator
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