Clinical trial: NCT00630565
Section: Alternatives
Subsections: Alternatives to Participation

You could receive the same treatment without participating in this data collection
research study. Alternative treatments include a donor (allogeneic) transplant or
additional chemotherapy. You may elect to receive other forms of treatment here or
elsewhere. You can also choose to not receive treatment at this time.
Clinical trial: NCT00630565
Section: Confidentiality
Subsections: Protected Health Information (PHI)|Confidentiality|Confidentiality

Your PHI created or received for the purposes of this study is protected under the
federal regulation known as HIPAA. Refer to the attached HIPAA authorization for
details concerning the use of this information.

All necessary steps will be undertaken to avoid identifying you in public presentations
except after your request and with written consent to do so. The results of this study
treatment may be published in scientific journals in the future, but no one (including you)
will be identified. Information concerning your transplant course may be transmitted to
appropriate national and international transplant registries, the Food and Drug
Administration (FDA) and other authorized study organizations. However, you will not
be identified by name in publications or reports released by such groups.  
If you decide to participate in this study, some private health information about you will
be stored in a computer database at the University of Minnesota Cancer Center. This
information will include your name and medical record number, your date of birth, your
diagnosis, your race/ethnicity, and information about your participation in this study.
The purpose of storing this information is to assist the Cancer Center in creating reports
about research and in making sure that research studies are being done correctly. Your
information will not be used for any other purpose. There are no plans to erase
information from the database. It will be stored indefinitely at the University of Minnesota
Cancer Center.  
Organizations that may inspect and/or copy your research for quality assurance and
data analysis include:  
The University of Minnesota Institutional Review Board (IRB), a group of
people who review the research study to protect your rights;  
Page 3 of 16

The University of Minnesota Masonic Cancer Center and/or their
designee
Government agencies including the Food and Drug Administration (FDA),
the Office for Human Research Protections, (OHRP), the National Cancer
Institute (NCI). These agencies may review the research to see that it is being
done safely and correctly.  
The University of Minnesota Masonic Cancer Center and/or their
designee  
Government agencies including the Food and Drug Administration (FDA),
the Office for Human Research Protections, (OHRP), the National Cancer
Institute (NCI). These agencies may review the research to see that it is being
done safely and correctly.  
If your records are copied for quality assurance or data analysis, your name and other
identifiers will be blacked out on the copies to preserve confidentiality.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by U.S. Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results. You can search this Web site
at any time.
Clinical trial: NCT00630565
Section: Participant's Rights
Subsections: New Information|Contacts and Questions|Contacts and Questions

If during the course of this research study, significant new findings are discovered which
might influence your willingness to continue, the researchers will inform you of those
developments.

This research has been reviewed and approved by an Institutional Review Board (IRB)
within the Human Research Protections Program (HRPP). To share feedback privately
with the HRPP about your research experience, call the Research Participants'
Advocate Line at 612-625-1650 or go to www.irb.umn.edu/report.html. You are
encouraged to contact the HRPP if:  
Page 4 of 16

Your questions, concerns, or complaints are not being answered by the research
team.
You cannot reach the research team.
You want to talk to someone besides the research team.
You have questions about your rights as a research participant.
You want to get information or provide input about this research.  
Your questions, concerns, or complaints are not being answered by the research
team.  
You cannot reach the research team.  
You want to talk to someone besides the research team.  
You have questions about your rights as a research participant.  
You want to get information or provide input about this research.  
Page 5 of 16
Clinical trial: NCT00630565
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Benefits|Risks/Discomforts|Compensation|Appendix B - Risks of Standard Treatment|Appendix B - Risks of Standard Treatment|Appendix B - Risks of Standard Treatment|Risks of Total Body Irradiation|||||||

There may not be benefits to you or others from your taking part in this research.
However, possible benefits to others include helping researchers learn new information
that may help people in the future.  
Page 2 of 16

The only risk to agreeing to this data collection study is a small risk of loss of
confidentiality. Your name and other direct identifiers will be stored in both the Cancer
Center's database and the BMT database, although both of them reside on the
University Of Minnesota computer server and are restricted in their access. No
information directly identifying you will be presented or published by this study.  
The risks of the standard of care treatment are listed in Appendix B of this document.

In the event that this research activity results in an injury, treatment will be available,
including first aid, emergency treatment and follow-up care as needed. Care for such
injuries will be billed in the ordinary manner, to you or your insurance company. If you
think that you have suffered a research related injury let the study physicians know right
away.

Transplant risks: Many of the risks involved in being in this study are the basic risks of
undergoing a bone marrow or stem-cell transplant in the first place. You'd have those
risks even if you had a transplant without being in a study.  
RISKS OF STEM CELL TRANSPLANTATION  
The following problems may occur as a result of the transplantation of stem cells; these
are risks that would be present whether such a transplant was done as part of a study
or not:  
1.
Slow recovery of blood counts. The red blood cells, white blood cells and
platelets can be slow to recover after stem cell transplantation. Until your counts
recover you will be dependent on blood and platelet transfusions, and will be at
risk
for bleeding and infection. Although infections can be treated with
antibiotics, occasionally they can be very dangerous or fatal.
2.
Graft Failure. The stem cells (the "graft") may fail to grow up inside your body at
all. If graft failure occurs, this will result in low blood counts for a long period of
time and can be fatal. Should this happen, you may be able to receive a second
transplant with stem cells from another person (e.g. a different umbilical cord
blood donor or a matched or mismatched parent or brother or sister).
3.
Other complications that can result from the transplantation procedure not
specifically related to one specific drug or the stem cells or this study include:
A.
Damage to the vital organs in your body. This could result in
malfunction of any organ in your body such as heart, lungs, liver, gut,
kidneys and bladder, brain etc. The lungs and the liver are particularly
vulnerable. Some patients will experience severe lung problems due to
infections and/or due to a reaction of the lungs to the chemotherapy and
radiation. Some patients can suffer veno-occlusive disease of the liver
(VOD). This is a complication that may result from high doses of
chemotherapy and/or radiation. Patients who have VOD
become
jaundiced (yellowish skin), have liver function abnormalities, abdominal
swelling, and abdominal pain. Although many patients recover completely,
these complications may result in organ failure and permanent damage or
even death.
B.
Serious infections. Full and complete recovery of your immune system
may take many months following the initial recovery of your white cell
count. During this time, there is an increased risk of infections. You will be
prescribed certain medications to reduce the chance of those infections.
However, preventative treatments are not always effective. If you have an
infection, you may have to stay in the hospital longer or be re-hospitalized
after transplant. Infections can be fatal.  
1.
Slow recovery of blood counts. The red blood cells, white blood cells and
platelets can be slow to recover after stem cell transplantation. Until your counts
recover you will be dependent on blood and platelet transfusions, and will be at
risk
for bleeding and infection. Although infections can be treated with
antibiotics, occasionally they can be very dangerous or fatal.  
2.
Graft Failure. The stem cells (the "graft") may fail to grow up inside your body at
all. If graft failure occurs, this will result in low blood counts for a long period of
time and can be fatal. Should this happen, you may be able to receive a second
transplant with stem cells from another person (e.g. a different umbilical cord
blood donor or a matched or mismatched parent or brother or sister).  
3.
Other complications that can result from the transplantation procedure not
specifically related to one specific drug or the stem cells or this study include:  
A.
Damage to the vital organs in your body. This could result in
malfunction of any organ in your body such as heart, lungs, liver, gut,
kidneys and bladder, brain etc. The lungs and the liver are particularly
vulnerable. Some patients will experience severe lung problems due to
infections and/or due to a reaction of the lungs to the chemotherapy and
radiation. Some patients can suffer veno-occlusive disease of the liver
(VOD). This is a complication that may result from high doses of
chemotherapy and/or radiation. Patients who have VOD
become
jaundiced (yellowish skin), have liver function abnormalities, abdominal
swelling, and abdominal pain. Although many patients recover completely,
these complications may result in organ failure and permanent damage or
even death.  
B.
Serious infections. Full and complete recovery of your immune system
may take many months following the initial recovery of your white cell
count. During this time, there is an increased risk of infections. You will be
prescribed certain medications to reduce the chance of those infections.
However, preventative treatments are not always effective. If you have an
infection, you may have to stay in the hospital longer or be re-hospitalized
after transplant. Infections can be fatal.  
Page 11 of 16

C.
Recurrence of disease. Your disease may recur even if the transplant is
initially successful.
D.
Risk to the Unborn: The treatments in this study have NOT been proven
to be safe at any stage of pregnancy. Therefore, if you are pregnant or
nursing, you are not eligible for this study. Women who have the potential
of becoming pregnant must use some form of effective birth control.
Effective birth control would be defined as the following: 1) refraining from
all acts of vaginal intercourse (ABSTINENCE); 2) consistent use of birth
control pills; 3) injectable birth control methods (Depo-Provera, Norplant);
4) tubal sterilization or male partner who has undergone a vasectomy; 5)
placement of an IUD (intrauterine device); and, 6) use, with every act of
intercourse, of a diaphragm with contraceptive jelly and/or condoms with
contraceptive foam.
E.
Sterility and Future Childbearing Potential for Men and Women:
Chemotherapy and/or irradiation may affect fertility. Male patients may
become sterile (unable to produce sperm). Female patients may find that
their menstrual cycle becomes irregular or stops permanently. However,
this DOES NOT MEAN THAT YOU CANNOT BECOME PREGNANT, and
you must use some effective method of birth control. Damage to
reproductive tissue may result in birth defects or permanent inability to
father a child or become pregnant. You should discuss these risks and
options in detail with your doctor before entering this study.
F.
Central Venous Catheter: There has been considerable experience with
central venous catheter use. The most common complications are clotting
and local infection which sometimes lead to a generalized infection in the
blood. Clotting may require the catheter to be removed or treatment with a
fibrinolytic agent (medicines that dissolve blood clots). Infections will be
treated with antibiotics, and sometimes, removal of the catheter is required.
Occasionally, skin redness at the catheter exit site occurs, this may require
antibiotic treatment. There is also a small risk of puncturing the lung at the
time of the catheter insertion. If this occurs, placement of a temporary chest
tube to reinflate the lung may be required. There are no long-term effects
once the lung puncture has resolved.  
C.
Recurrence of disease. Your disease may recur even if the transplant is
initially successful.  
D.
Risk to the Unborn: The treatments in this study have NOT been proven
to be safe at any stage of pregnancy. Therefore, if you are pregnant or
nursing, you are not eligible for this study. Women who have the potential
of becoming pregnant must use some form of effective birth control.
Effective birth control would be defined as the following: 1) refraining from
all acts of vaginal intercourse (ABSTINENCE); 2) consistent use of birth
control pills; 3) injectable birth control methods (Depo-Provera, Norplant);
4) tubal sterilization or male partner who has undergone a vasectomy; 5)
placement of an IUD (intrauterine device); and, 6) use, with every act of
intercourse, of a diaphragm with contraceptive jelly and/or condoms with
contraceptive foam.  
E.
Sterility and Future Childbearing Potential for Men and Women:
Chemotherapy and/or irradiation may affect fertility. Male patients may
become sterile (unable to produce sperm). Female patients may find that
their menstrual cycle becomes irregular or stops permanently. However,
this DOES NOT MEAN THAT YOU CANNOT BECOME PREGNANT, and
you must use some effective method of birth control. Damage to
reproductive tissue may result in birth defects or permanent inability to
father a child or become pregnant. You should discuss these risks and
options in detail with your doctor before entering this study.  
F.
Central Venous Catheter: There has been considerable experience with
central venous catheter use. The most common complications are clotting
and local infection which sometimes lead to a generalized infection in the
blood. Clotting may require the catheter to be removed or treatment with a
fibrinolytic agent (medicines that dissolve blood clots). Infections will be
treated with antibiotics, and sometimes, removal of the catheter is required.
Occasionally, skin redness at the catheter exit site occurs, this may require
antibiotic treatment. There is also a small risk of puncturing the lung at the
time of the catheter insertion. If this occurs, placement of a temporary chest
tube to reinflate the lung may be required. There are no long-term effects
once the lung puncture has resolved.  
Priming risks: The three-day treatment with chemotherapy (Cyclophosphamide,
Etoposide, and Dexamethasone) to obtain peripheral blood stem cells can produce
substantial nausea and vomiting, as well as an increased risk of infections. All patients
undergoing transplant develop major suppression of their blood counts requiring
transfusions of red cells and platelets and extreme vulnerability to life-threatening
infections. Along with the above mentioned side effects, hair loss, mouth sores and
infertility are expected after this intensity of treatment. Some patients may develop  
Page 12 of 16

injury to the heart or lungs which might become life-threatening or fatal. Bladder
irritation from cyclophosphamide (hemorrhagic cystitis) may cause urinary pain or
bleeding. Another risk is eventual relapse of the leukemia despite the transplant.  
Chemotherapy Risks: To allow the new bone marrow to "take" or grow after
transplantation, you will receive radiation, cyclophosphamide and growth factors. The
major side-effects of chemotherapy and radiation are nausea, vomiting, diarrhea, hair
loss and mouth sores. Your blood counts (red cells, white cells and platelets) will be
lowered and red cell and platelet transfusions will be needed to maintain safe blood
counts. Also, various kinds of infections may be possible and high fever or other signs
or symptoms of serious or life-threatening infections may develop. Your doctors will
watch for infection or bleeding problems and treat them as needed.  
The priming/chemotherapy drugs may cause the following side effects:

The immediate effects of irradiation may include nausea, vomiting, diarrhea, loss of
appetite, painful swelling of the salivary gland under the jaw for a few days, and
temporary hair loss. TBI may lower your blood counts. TBI has been associated with
causing sterility. Although TBI can theoretically cause abnormalities in children born to
transplant survivors, the incidence of genetic abnormalities has not been reported to be
greater than the general population. However, this is a potential risk and birth control
should be used for at least one year after transplant to minimize risks of conceiving. In
addition, there may be a small increased risk of developing other cancers in the future as
a consequence of having received TBI and chemotherapy. Cancers that are caused by
treatment with chemotherapy or radiation are often fatal.  
Page 16 of 16

| Common occurs in more than 20% of patients                                                                                                                                                                               | Less Common occurs in 5 to 20% of patients                                                                                                                                              | Rare occurs in fewer than 5% of patients                                                  |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Decreased white blood cell count with increased risk of infection Hair loss Nausea Vomiting Loss of appetite Sores in mouth or on lips Diarrhea Stopping of menstrual periods in women Decreased sperm production in men | Decreased platelet count (mild) with increased risk of bleeding Blood in urine Darkening of nail beds Acne Tiredness Fetal changes if you become pregnant while taking cyclophosphamide | Scarring of lung tissue, with cough and shortness of breath Heart changes with high doses |



|                                                                                                                                                                       |                                                                     |                                                                                                              |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Common occurs in more than 20% of patients                                                                                                                            | Less Common occurs in 5 to 20% of patients                          | Rare occurs in fewer than 5% of patients                                                                     |
| Decreased white blood cell count with increased risk of infection Decreased platelet count with increased risk of bleeding Mild nausea Mild vomiting Loss of appetite | Constipation Diarrhea Pain in stomach Radiation recall skin changes | Decrease in blood pressure Difficulty breathing during drug infusion Rash Itching Heart changes Numbness and |



|                                                                                                                      |                                            |                                                                                                     |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common occurs in more than 20% of patients                                                                           | Less Common occurs in 5 to 20% of patients | Rare occurs in fewer than 5% of patients                                                            |
| Changes in taste including metallic taste of foods Hair loss Fetal damage if pregnancy occurs while taking this drug |                                            | tingling in hands and/or feet related to nerve irritation or damage Fever Chills Allergic reactions |



|                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                       |                                                                                         |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Common occurs in more than 20% of patients                                                                                                                                                                                                                                     | Less Common occurs in 5 to 20% of patients                                                                                                                                                                                                                                            | Rare occurs in fewer than 5% of patients                                                |
| Weight gain Sodium and fluid retention with swelling of ankles, increased blood pressure, congestive heart failure Depression Increased blood sugar Increased appetite . Sleep disturbance Increased risk of infection Bruising of the skin Mood changes Delayed wound healing | Decrease in serum potassium (symptoms are loss of appetite, muscle twitching, increased thrist, increased urination) Fracture of weak bones Fungal infections(white patches in mouth, vagina) Sweating Diarrhea Nausea . Headache . Increased heart rate . Loss of calcium from bones | Cataracts Personality changes Blurred vision Stomach ulcer which may bleed (hemorrhage) |



| Common                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Less Common occurs in 5 to 20% of patients                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Rare                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| occurs in more than 20% of patients                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | occurs in fewer than 5% of patients                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
| Nausea and vomiting Fever Headache Bloody nose Fewer red and white blood cells and platelets in the blood Dizziness Difficulty sleeping Mood changes including depression and anxiety Rash with itching and/or hives Pain and inflammation in the vein through which the drug is given Back pain or pain in the abdomen Diarrhea or constipation Rectal pain or discomfort Loss of Appetite A fast heart beat which may cause pain in the chest Shortness of breath Fluid build-up in the tissues usually of the lower legs Inflammation and/or sores in the mouth, throat and/or esophagus Absence or decrease in the number of sperm and/or damage to the testis which may be temporary or permanent which may decrease the ability to have children in the future Absence of menstrual cycles (periods) and damage to the ovaries that may decrease the ability to have children in the future Lower levels of certain salts in the blood such as calcium, magnesium, phosphate, and | Weight gain Confusion Temporary hair loss or thinning Aches and pains in the muscles and joints Increased levels of creatinine in the blood which could mean kidney damage Darkening of the skin Elevation in the blood of certain enzymes found in the liver Inflammation or damage to the liver which can be severe and life-threatening and which may lead to an enlarged liver and spleen, bleeding from the veins in the esophagus (the passage that leads from the throat to the stomach), a yellow appearing skin, and fluid collection in the abdomen which makes it look larger. Damage to the bladder which can lead to large amounts of blood in the urine, pain and the urge to urinate frequently and also scarring of the bladder Elevation in uric acid in the blood Redness and burning at sites which have | Convulsions Vomiting blood Bleeding into the lungs A new cancer or leukemia resulting from this treatment Abnormal heart rate Damage to the adrenal glands that may affect the hormones that maintain blood pressure and prevent shock in stressful situations Damage to the lungs that can lead to fluid in the lungs and/or scarring of the lung tissue, cough, and affect your ability to breath and the levels of oxygen in your blood. Scarring of the heart muscle which could lead to heart failure Damage to the bone which could lead to arthritis pain and weakness of the bone |



|                                                                                                                                                                         |                                                                                  |                                          |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------|
| Common occurs in more than 20% of patients                                                                                                                              | Less Common occurs in 5 to 20% of patients                                       | Rare occurs in fewer than 5% of patients |
| sodium High blood sugar which may require treatment Elevation in the blood of bilirubin found in the liver A feeling of discomfort or not feeling well and/or tiredness | received radiation in the past Cataracts later in life Enlargement of the breast |                                          |



|                                            |                                                                                                                                             |                                                                                                                                                                              |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common occurs in more than 20% of patients | Less Common occurs in 5 to 20% of patients                                                                                                  | Rare occurs in fewer than 5% of patients                                                                                                                                     |
| Ache or pain inside the bones              | Local irritation at injection site Increased levels of liver enzymes and uric acid in the blood, low number of platelets in the blood fever | Allergic reaction, low fever Enlargement of the spleen and even splenic rupture worsening of pre- existing skin rashes, hair loss Inflammation of a blood vessel in the skin |
Clinical trial: NCT00630565
Section: Procedures
Subsections: Background Information|Pre-transplant evaluation:|Treatment|Treatment|Treatment|Follow-up and Care After the Transplant||

You have acute non-lymphocytic leukemia (AML), a cancer of the bone marrow. It is
likely that the cancer will return despite treatment including chemotherapy. Because
these diseases are unlikely to be cured with conventional treatment and your doctors
expect your disease to progress after the treatment you have already received, you are
invited to join this autologous transplant study. The therapy is designed to aggressively
treat your disease and reduce the chances that it will recur. This approach uses high
doses of chemotherapy in an attempt to reverse the disease process. Because this
therapy eliminates normal bone marrow as a side effect, new bone marrow or stem cells
must be supplied.  
There are four steps to this treatment:  
1.
Priming - prepare the stem cells in your body for harvest
2.
Harvest - remove stem cells from your body
3.
Chemotherapy - treat your disease and prepare your body for transplant
4.
Transplant give you back the harvested cells  
1.
Priming - prepare the stem cells in your body for harvest  
2.
Harvest - remove stem cells from your body  
3.
Chemotherapy - treat your disease and prepare your body for transplant  
4.
Transplant give you back the harvested cells  
These steps are all standard treatment for AML. A treatment plan summary about each
of these steps is in Appendix A of this consent.

If you decide to take part in this study and have signed the informed consent, you will be
evaluated to make sure it is safe for you to participate in the study. Before starting
treatment in this study, your doctor will check your general health. You will have the
following tests and evaluations to find out if you can participate:  
Medical history and physical examination, including height and weight.
Blood tests (approximately 5 tablespoons)
30 ml (2 tablespoons or 1 oz) of blood will be drawn to test for
exposure to Hepatitis, and to have blood tests performed. You have the
right to request to review the results of all tests. If your initial blood tests
are abnormal, you will be notified of this. We will suggest that a Blood
Bank physician contact your personal physician regarding possible further
studies and the significance of any positive tests. We must also notify the
Minnesota Department of Health if you are found to have Hepatitis. If you
have Hepatitis we will refer you to the appropriate physicians and
counselors.
Urine tests
Electrocardiogram (ECG or EKG), a picture of the electrical action
of the heart)
Echocardiogram (a picture of the heart in motion made using
ultrasound or sound waves) or MUGA scan (a picture of your heart after a
small amount of radioactive material is injected into the bloodstream
through a vein) to evaluate your heart function
Pulmonary Function Test (PFT), which is a breathing test that tells
how your lungs are working, measures the amount of air taken into your
lungs and exhaled as you breath)
Bone marrow biopsies and aspirates. A bone marrow aspiration is a
procedure where an area of the hipbone is numbed and a small sample of
bone marrow is withdrawn. A bone marrow biopsy is similar to an
aspiration, except a sample of bone is removed through the needle.
If you are a woman able to have children, a serum pregnancy test
will also be performed. If you are pregnant, you will not be able to take
part in this study.  
Medical history and physical examination, including height and weight.  
Blood tests (approximately 5 tablespoons)  
30 ml (2 tablespoons or 1 oz) of blood will be drawn to test for
exposure to Hepatitis, and to have blood tests performed. You have the
right to request to review the results of all tests. If your initial blood tests
are abnormal, you will be notified of this. We will suggest that a Blood
Bank physician contact your personal physician regarding possible further
studies and the significance of any positive tests. We must also notify the
Minnesota Department of Health if you are found to have Hepatitis. If you
have Hepatitis we will refer you to the appropriate physicians and
counselors.  
Urine tests  
Electrocardiogram (ECG or EKG), a picture of the electrical action
of the heart)  
Echocardiogram (a picture of the heart in motion made using
ultrasound or sound waves) or MUGA scan (a picture of your heart after a
small amount of radioactive material is injected into the bloodstream
through a vein) to evaluate your heart function  
Pulmonary Function Test (PFT), which is a breathing test that tells
how your lungs are working, measures the amount of air taken into your
lungs and exhaled as you breath)  
Bone marrow biopsies and aspirates. A bone marrow aspiration is a
procedure where an area of the hipbone is numbed and a small sample of
bone marrow is withdrawn. A bone marrow biopsy is similar to an
aspiration, except a sample of bone is removed through the needle.  
If you are a woman able to have children, a serum pregnancy test
will also be performed. If you are pregnant, you will not be able to take
part in this study.  
Some additional tests may be done to evaluate your disease. These tests will help your
doctor determine the amount of disease you have at the start of treatment and to follow
the status of your disease throughout your treatment.

If the pre-transplant evaluation demonstrates that transplantation treatment may be
appropriate, the treatment course will be as follows.  
Page 8 of 16

1.
Catheter: A large double-port catheter will be surgically put into a large
vein leading towards your heart, if one is not already in place. This catheter will
be used for giving chemotherapy and drawing blood. It will also be used for
giving transfusions and antibiotics as needed during the transplant course. This
type of catheter is routinely used for all transplant patients.
2.
Priming the Body for Stem Cell Harvest: For harvesting of peripheral
blood stem cells, in order to decrease the number of leukemic cells, increase the
number of healthy, non-leukemic cells and increase the number and growth
potential of peripheral blood stem cells, you will be given high doses (priming
dose) of the anti-cancer agents, cyclophosphamide (1 day), etoposide (2 days),
and dexamethasone (2 days) in the hospital. A daily injection of a blood growth
factor called G-CSF (granulocyte-colony stimulating factor) begins after the
chemotherapy is completed and is given on a daily basis in the clinic. As your
marrow and peripheral blood cell counts are returning to normal levels a
peripheral blood harvest will be performed.
3.
Stem Cell Mobilization: To get the stem cells needed for the transplant,
peripheral blood stem cells will be used if possible. If there is a reason that it is
not safe to collect stem cells from the blood, bone marrow may be harvested in
the operating room. A drug that increases the number of marrow cells, called
GM-CSF (granulocyte-macrophage colony stimulating factor) will be given every
day subcutaneously for 5 days in the clinic prior to collecting marrow to increase
the number of marrow cells should this be necessary.
4.
Stem Cell Harvest: Peripheral blood stem cells are collected by
leukaphoresis (removal of white blood cells with a continuous flow centrifuge) in
the Blood Bank Donor Center. At least four of these blood stem cell collection
procedures (lasting 4-5 hours each) will be performed, unless fewer collections
obtain enough cells. If enough cells are not obtained, then you will be scheduled
for a bone marrow harvest in the operating room (you will be given a consent to
sign for that procedure). You will have 1 week with no growth factors, followed
by 1 dose subcutaneously every day for five days of GM-CSF (granulocyte-
macrophage colony stimulating factor) as an outpatient before the marrow is
harvested.
5.
Chemotherapy and Irradiation: Before the transplant, to kill the leukemia
cells you will undergo chemotherapy and radiation, or chemotherapy alone. The
doctors will determine which of these treatments is best for you, depending on
whether or not you are able to receive radiation.
Chemotherapy and Irradiation: You will be given total body
irradiation twice daily for 4 days (7, 6, 5 and 4 days before the transplant)
followed by high-dose chemotherapy (cyclophosphamide given 3 and 2
days before transplantation). You will then receive intravenous reinfusion  
1.
Catheter: A large double-port catheter will be surgically put into a large
vein leading towards your heart, if one is not already in place. This catheter will
be used for giving chemotherapy and drawing blood. It will also be used for
giving transfusions and antibiotics as needed during the transplant course. This
type of catheter is routinely used for all transplant patients.  
2.
Priming the Body for Stem Cell Harvest: For harvesting of peripheral
blood stem cells, in order to decrease the number of leukemic cells, increase the
number of healthy, non-leukemic cells and increase the number and growth
potential of peripheral blood stem cells, you will be given high doses (priming
dose) of the anti-cancer agents, cyclophosphamide (1 day), etoposide (2 days),
and dexamethasone (2 days) in the hospital. A daily injection of a blood growth
factor called G-CSF (granulocyte-colony stimulating factor) begins after the
chemotherapy is completed and is given on a daily basis in the clinic. As your
marrow and peripheral blood cell counts are returning to normal levels a
peripheral blood harvest will be performed.  
3.
Stem Cell Mobilization: To get the stem cells needed for the transplant,
peripheral blood stem cells will be used if possible. If there is a reason that it is
not safe to collect stem cells from the blood, bone marrow may be harvested in
the operating room. A drug that increases the number of marrow cells, called
GM-CSF (granulocyte-macrophage colony stimulating factor) will be given every
day subcutaneously for 5 days in the clinic prior to collecting marrow to increase
the number of marrow cells should this be necessary.  
4.
Stem Cell Harvest: Peripheral blood stem cells are collected by
leukaphoresis (removal of white blood cells with a continuous flow centrifuge) in
the Blood Bank Donor Center. At least four of these blood stem cell collection
procedures (lasting 4-5 hours each) will be performed, unless fewer collections
obtain enough cells. If enough cells are not obtained, then you will be scheduled
for a bone marrow harvest in the operating room (you will be given a consent to
sign for that procedure). You will have 1 week with no growth factors, followed
by 1 dose subcutaneously every day for five days of GM-CSF (granulocyte-
macrophage colony stimulating factor) as an outpatient before the marrow is
harvested.  
5.
Chemotherapy and Irradiation: Before the transplant, to kill the leukemia
cells you will undergo chemotherapy and radiation, or chemotherapy alone. The
doctors will determine which of these treatments is best for you, depending on
whether or not you are able to receive radiation.  
Chemotherapy and Irradiation: You will be given total body
irradiation twice daily for 4 days (7, 6, 5 and 4 days before the transplant)
followed by high-dose chemotherapy (cyclophosphamide given 3 and 2
days before transplantation). You will then receive intravenous reinfusion  
Page 9 of 16

of all the previously collected and frozen stem cells. One day later, growth
factor (G-CSF) treatment will begin in order to accelerate blood recovery.  
Chemotherapy Alone: If you cannot receive radiation,
chemotherapy may be substituted for radiation. In this case, busulfan will
be given intravenously 7, 6, 5 and 4 days prior to the transplant in the
hospital, followed by 2 days of cyclophosphamide (3 and 2 days before
the transplant). After reinfusion of the stem cells, growth factor treatment
will be given to accelerate blood recovery.
6.
Transplant Day: On transplant day you will receive the stem cell
transplant, which is given intravenously through your line.  
Chemotherapy Alone: If you cannot receive radiation,
chemotherapy may be substituted for radiation. In this case, busulfan will
be given intravenously 7, 6, 5 and 4 days prior to the transplant in the
hospital, followed by 2 days of cyclophosphamide (3 and 2 days before
the transplant). After reinfusion of the stem cells, growth factor treatment
will be given to accelerate blood recovery.  
6.
Transplant Day: On transplant day you will receive the stem cell
transplant, which is given intravenously through your line.

Frequent physical exams and blood tests will be done to check for blood count recovery
and to look for side effects. During the first 2-3 weeks after the transplant, up to 2
tablespoons of blood will be drawn daily. Appropriate supportive care is given to all
patients after a transplant. This may include transfusions of red blood cells or platelets,
antibiotics to prevent or treat infections and drugs to encourage bone marrow recovery.  
Blood will be drawn less frequently as blood counts improve. Milestone blood samples
are taken at day 21, 28, day 100, 1 year and as required by medical status yearly for 2
years after transplant. Bone marrow aspirations are performed on day 28, 6 months,
one year, and 2 years if medically necessary.  
After blood count recovery and discharge from the hospital, at least weekly follow-up
visits in the outpatient clinic will occur for the 1st 3 months after the transplant. Routine
clinic follow-up is required at 6, 12 and 24 months after the transplant with at least
yearly contact (in person, by phone or mail) after that.  
Page 10 of 16

|    |                                                                        |
|----|------------------------------------------------------------------------|
|  1 | Priming - prepare the stem cells in your body for harvest              |
|  2 | Harvest - remove stem cells from your body                             |
|  3 | Chemotherapy - treat your disease and prepare your body for transplant |
|  4 | Transplant give you back the harvested cells                           |



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|    | Medical history and physical examination, including height and weight. Blood tests (approximately 5 tablespoons) 30 ml (2 tablespoons or 1 oz) of blood will be drawn to test for exposure to Hepatitis, and to have blood tests performed. You have the right to request to review the results of all tests. If your initial blood tests are abnormal, you will be notified of this. We will suggest that a Blood Bank physician contact your personal physician regarding possible further studies and the significance of any positive tests. We must also notify the Minnesota Department of Health if you are found to have Hepatitis. If you have Hepatitis we will refer you to the appropriate physicians and counselors. Urine tests Electrocardiogram (ECG or EKG), a picture of the electrical action of the heart) Echocardiogram (a picture of the heart in motion made using ultrasound or sound waves) or MUGA scan (a picture of your heart after a small amount of radioactive material is injected into the bloodstream through a vein) to evaluate your heart function Pulmonary Function Test (PFT), which is a breathing test that tells how your lungs are working, measures the amount of air taken into your lungs and exhaled as you breath) Bone marrow biopsies and aspirates. A bone marrow aspiration is a procedure where an area of the hipbone is numbed and a small sample of bone marrow is withdrawn. A bone marrow biopsy is similar to an aspiration, except a sample of bone is removed through the needle. If you are a woman able to have children, a serum pregnancy test will also be performed. If you are pregnant, you will not be able to take part in this study. |
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Clinical trial: NCT00630565
Section: Purpose of Research
Subsections: Blood and Marrow Transplant Program, University of Minnesota|Purpose of This Research

You are invited to be in a clinical research study. Taking part in any clinical research
involves risks and may provide some benefits. You need to understand these risks and
benefits to make an informed decision about whether or not to be in this study. This
research does not involve treatment and is data collection only.  
At the University of Minnesota, transplants are primarily done for blood related cancers
using someone other than the patient as a donor of the blood or bone marrow cells
used for the transplant. For this reason, in order to learn more about the outcomes of
transplants where patients are their own donors (autologous), you are being asked to
allow routine clinical data to be collected and maintained in OnCore, the Masonic
Cancer Center's (MCC) clinical database and specific transplant related endpoints in
the University Of Minnesota Blood and Bone Marrow Transplantation (BMT) Database.  
This form is called a consent form. The purpose of this form is to let you know about a
research study being done here at the University of Minnesota Medical Center. It tells
you about the purpose, risks and benefits, and describes what is involved in the study. It
also tells you what other choices you have. Once you understand the study. You will
be asked to sign this form if you wish to take part. To help you decide if you want to take
part in this study, you should:  
Read this form.
Write down your questions.
Ask your doctor questions about the study.
Have your doctor explain anything that you do not understand.
Discuss it with your family or close friends.
Take time to think about whether you want to take part in this study.  
Read this form.  
Write down your questions.  
Ask your doctor questions about the study.  
Have your doctor explain anything that you do not understand.  
Discuss it with your family or close friends.  
Take time to think about whether you want to take part in this study.  
You will have a copy to keep as a record.  
Although not part of this consent process, the description of a typical autologous
transplant with the expected risks is attached to this document. Your doctor may alter
this plan based on your individual disease and medical needs.  
Research studies only include people who want to take part in the study. Please
take time to make your decision. We encourage you to discuss your decision
with your doctors, family, and friends. You will receive all appropriate medical
care whether or not you decide to be in the study.  
Page 1 of 16

The primary purpose of this study is to record outcomes and patient characteristics in
the Cancer Center's and BMT databases for patients who are undergoing
an
autologous transplant for the treatment of AML. The data will be analyzed for transplant
"milestones" such as time to blood count recovery and how patients are doing at 3
months, 6 months, 1 year and 2 years after the transplant.
Clinical trial: NCT00630565
Section: Voluntary Participation
Subsections: Contacts and Questions|Contacts and Questions

I have read the above information and have had adequate opportunity to discuss my
questions. I consent to participate in this study.  
Printed name of the subject
Signature of subject
Date
I have explained fully the above objective of this study, what is to be expected, and the
possible complications.
Printed name of counseling physician
Signature of the counseling physician
Date  
IF USING A SHORT FORM TO CONSENT, THE WITNESS SIGNATURE BLOCK
MUST BE COMPLETED BELOW:  
My signature below documents that the information in the consent document and any
other written and information was accurately explained to, and apparently understood
by, the participant, and that consent was freely given by the participant.  
Signature of Witness to Consent Process  
Date  
Printed Name of Person Witnessing Consent Process  
Page 6 of 16

Your signature documents your permission for the named participant to take part in this
research.  
Printed Name of Participant
Signature of Legally Authorized Representative
Date
Printed Name of Legally Authorized Representative
Date
Signature of Person Obtaining Consent
Date
Printed Name of Person Obtaining Consent
Date  
Page 7 of 16
Clinical trial: NCT00630565
Section: Withdrawal from Study
Subsections: Voluntary Nature of the Study

You are free to withdraw from participation in this study at any time, for any reason.
However, withdrawal after initiation of treatment could be life-threatening or even fatal,
and may not be reasonable. A decision not to participate or withdraw at a later time will
not jeopardize your ability to receive medical care at present or in the future. Your
decision to participate in this research is voluntary.