Clinical trial: NCT02109744
Section: Confidentiality
Subsections: Who Will See My Medical Information? Confidentiality Of Records And Authorization To Use And Disclose Information For Research Purposes|How Will Information About Me Be Kept Private?

The University of Rochester makes every effort to keep the information collected from you private. In order to do so, we will restrict access of study materials only to those personnel directly involved in the research, ensure all staff involved has been properly trained, and keep matierials in proper storage. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor. If you have never received a copy of the University of Rochester Medical Center (URMC) and Affiliates Notice of Privacy Practices, please ask the investigator for one. What information may be used and given to others? The study doctor will get your personal and medical information. For example:
Research records Records about phone calls made as part of this research Records about your study visits Past and present medical records related to the study (only if you will be collecting information from the medical record)
Results of medical tests (only if you will be conducting medical testing, labs, imaging, etc.)
Who may use and give out information about you?  
The study doctor and the study staff URMC and Affiliates Your information may be given to:
The Department of Health and Human Services; The University of Rochester The U.S. Food and Drug Administration (FDA) may also need to inspect study records at some point during the study or even after it has been completed. In the event that this should occur, every effort will be made to keep identifying information about you private.  
Why will this information be used and/or given to others?  
to do the research, to study the results, and to see if the research was done right If the results of this study are made public, information that identifies you will not be used. What if I decide not to give permission to use and give out my health information? Then you will not be able to be in this research study. May I review or copy my information? Yes, but only after the research is over. How long will this be permission be valid? This permission will last indefinitely. [If you will destroy the records at a definite point that should be stated instead and should be consistent with what is listed in both your protocol and application.]

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
When your sample(s) is sent to the researchers, no information identifying you (such as your name)
will be sent. Samples will be identified by a unique code only.  
The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank staff or reserachers with access to the list must sign an agreement to keep your identity confidential.  
Researchers to whom the University of Rochester sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
Information that identifies you will not be given to anyone, unless required by law.  
If research results are published, your name and other personal information will not be used.
Clinical trial: NCT02109744
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

You may receive decitabine followed by rapamcycin or ribavirin for up to 6 cycles of 28 days (about 6 months). After you finish these cycles, your doctor will continue to watch you for side effects and follow your condition for up to 2 years. Your doctor may or may not continue other treatments when the 6 cycles are concluded.
Clinical trial: NCT02109744
Section: Participant's Rights
Subsections: What Are My Rights In This Study?|May I Cancel My Permission To Use And Disclose Information?

Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner. If we discover anything that might make you change your mind about continuing in the study, we will let you know. For questions about your rights while in this study, call the University of Rochester Institutional Review Board at (585) 276-0005. For long-distance you may call toll-free: (877) 449-4441.

You may cancel your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. Upon receiving the written notice, the study team will no longer use or disclose your health information and you will not be able to stay in this study. Information that has already been gathered may need to be used and given to others for the validity of the study.
Clinical trial: NCT02109744
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Side Effects Of Blood Sample Collection|Risks And Side Effects Of Bone Marrow Aspirate And Biopsy|What Possible Risks Can I Expect From Taking Part In This Study?|Possible Side Effects Of Decitabine Common, Some May Be Serious|Rare, And Serious|Rare, And Serious|Possible Side Effects Of Ribavirin|Rare, And Serious|Rare, And Serious|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Are The Possible Risks?

Obtaining blood samples may cause pain and bruising. Fainting, and in rare cases infection, may also occur. If you have an indwelling central line or port, every effort will be made to use that for blood testing during the study.

Possible side effects of bone marrow aspirate and biopsy include bleeding, infection, bruising, discomfort at the biopsy site and possible side effects from the local anesthetic (pain or bruising at the site where the aspirate or biopsy occurs). During the bone marrow biopsy and aspiration, you may have a reaction to the local anesthetic.

If you choose to take part in this study, there is a risk that:
You may lose time at work or home and spend more time in the hospital or doctor's office than usual The combination of decitabine with ribavirin or rapamycin may not be better, and could possibly be worse, than the usual approach for your cancer.  
The drugs used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will be testing your blood and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the study drug(s)/study approach.  
Here are important points about side effects:
Some side effects may go away soon, some may last a long time, or some may never go away. Some side effects may interfere with your ability to have children.  
Some side effects may be serious and may even result in death.  
Here are important points about how you and the study doctor can make side effects less of a problem:
Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.  
The study doctor may be able to treat some side effects. The study doctor may adjust the study drugs to try to reduce side effects.  
The tables below show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you. Arms A and B- Possible side effects of DECITABINE, which is a usual approach for this type of cancer:

In 100 people receiving DECITABINE, more than 20 and up to 100 may have:
Changes to blood composition (including one to three of the following)
Low number of white cells: may increase the chance of infections, including pneumonia, fever of unknown origin, urinary tract infection, infection or irritation of the mouth, sinusitis and sepsis, a blood-stream infection caused by the presence of bacteria or other infectious organisms or their toxins in the blood.  
Low number of platelets: increases the chance of bleeding; this may show up as small bleeding spots in the skin, bleeding from the nose or gums and, rarely, bleeding in the stomach or brain.  
Low number of red cells (anemia): this may lead to pallor, fatigue, shortness of breath, dizziness or worsening of the function of the heart.  
Headache Nausea Vomiting Diarrhea Constipation Fever Hyperglycemia (elevated blood sugars)
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving DECITABINE, from 4 to 20 may have:
Ulceration of the tongue or lip Loss of appetite Sleeplessness Cough Hair loss Redness of skin Changes in liver or kidney function Back pain, joint pain or muscle pain RARE, AND SERIOUS
In 100 people receiving DECITABINE, 3 or fewer may have:
Seizures Septic shock Death may occur due to infection or bleeding.  
ARM A: Possible side effects of rapamycin which those on this arm could expect in addition: Possible Side Effects of RAPAMYCIN
COMMON, SOME MAY BE SERIOUS
In 100 people receiving RAPAMYCIN, more than 20 and up to 100 may have:
Trouble sleeping Nervousness Increased appetite Indigestion Inflammation of espophagus (food pipe)
Excess hair growth Diabetes (blood sugar elevations) Joint pain Cataracts Too much fat or cholesterol in the blood Suppression of immune system OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving RAPAMYCIN, from 4 to 20 may have:
Joint pain Cataracts Nosebleeds Headache Fluid and water retention Increased glucose levels in blood

In 100 people receiving RAPAMYCIN, 3 or fewer may have:
Seizures Mood swings Delirium or hallucinations Thinning of skin Bruising Darkening of skin Acne Loss of menstrual periods in females Suppression of bone growth Swelling of the abdomen Ulcers in the esophagus Inflammation of the pancreas Scarring in the lungs Arm B- In addition to side effects outlined above, people who are in Arm B may also experience the possible side effects of ribavirin listed below.

In 100 people receiving ribavirin, 3 or fewer may have:
Liver failure (only seen in patients with hepatitis C) Serious skin reactions Acute allergic reaction Increased pressure in the lungs Inflammation of the pancreas Let your study doctor know of any questions you have about possible side effects. You can ask the study doctor questions about side effects at any time. Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study. Decitabine, rapamycin, or ribavirin used in this study could be very damaging to an unborn baby. Check with the study doctor about what types of birth control, or pregnancy prevention, to use while in this study.

COMMON, SOME MAY BE SERIOUS
In 100 people receiving ribavirin, more than 20 and up to 100 may have:
Anemia due to breakdown of red blood cells (seen mostly in patients with hepatitis)
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving ribavirin, from 4 to 20 may have:
Anemia of other types which may require blood transfusion Low white cell count Low platelet count Itching of skin Low calcium Low magnesium Shortness of breath Pneumonia

In 100 people receiving RAPAMYCIN, 3 or fewer may have:
Seizures Mood swings Delirium or hallucinations Thinning of skin Bruising Darkening of skin Acne Loss of menstrual periods in females Suppression of bone growth Swelling of the abdomen Ulcers in the esophagus Inflammation of the pancreas Scarring in the lungs Arm B- In addition to side effects outlined above, people who are in Arm B may also experience the possible side effects of ribavirin listed below.

In 100 people receiving ribavirin, 3 or fewer may have:
Liver failure (only seen in patients with hepatitis C) Serious skin reactions Acute allergic reaction Increased pressure in the lungs Inflammation of the pancreas Let your study doctor know of any questions you have about possible side effects. You can ask the study doctor questions about side effects at any time. Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study. Decitabine, rapamycin, or ribavirin used in this study could be very damaging to an unborn baby. Check with the study doctor about what types of birth control, or pregnancy prevention, to use while in this study.

If you are directly injured by the drugs that are being studied, or by clinical procedures solely required to participate in the study, you may need to pay for treatment of your injuries, but you will not be required to pay for emergency medical treatment provided at Strong Memorial Hospital or Highland Hospital. The University may seek payment for this care from your health insurer or third parties. Decisions regarding care and compensation for any other research related injury will be made on a case-by-case basis.

The most common risks related to drawing blood from your arm are brief pain and possibly a bruise.  
There is a risk that someone could get access to the personal information in your medical records or other information researchers have stored about you.  
There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.
Clinical trial: NCT02109744
Section: Procedures
Subsections: What Extra Tests And Procedures Will I Have If I Take Part In This Study?|Blood And Bone Marrow Collection For The Study

Most of the exams, tests, and procedures you will have are part of the usual approach for your leukemia. However, there are some extra tests or procedures that you will need to have if you take part in this study. Before you begin the study: You will need to have the following extra tests and procedures to find out if you can be in the study beyond what might be performed if you chose alternate treatments:
Blood sample (approximately 2 tablespoons) for future research purposes only A bone marrow aspirate and biopsy (within 2 weeks prior to treatment). If you had a biopsy within 2 weeks, only an aspirate will need to be repeated to determine baseline blasts and to obtain a sample for future research purposes

Blood and marrow research specimens are required for you to take part in this study because the research on the sample is an important part of the study. The blood and marrow draws will be done just as they would for diagnosis and followup, and most would need to be done in any case to monitor the status of your leukemia. The extra amounts taken for research will help to understand if the decitabine and rapamycin or ribavirin are working on blood and marrow cells as expected but will not determine your treatment course on this study.
Clinical trial: NCT02109744
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages and in the treatment of newly diagnosed leukemia in those are older than 65 when diagnosed. The safety of this combination has been previously studied but it is considered investigational for the treatment of refractory or relapsed leukemia. The study will determine whether this combination is not only safe but has benefit in reducing the amount of leukemia present in these patients. There will be up to 24 patients taking part in this portion of the study. Both decitabine and rapamycin have approval from the FDA but not when used in this combination for leukemia. Because some patients who have M4 and M5 leukemia (types that are determined by the pathology doctor who reviewed the blood and marrow at diagnosis) may have changes in their cells that would make it more difficult for rapamycin to inhibit their leukemia, in those cases, we will combine decitabine with ribavirin which has also been shown to have ability to inhibit leukemia cells. The purpose of this portion of the study will be to determine the highest dose of ribavirin that can be given safely in combination with decitabine in M4and M5 types of leukemia. Up to 18 patients with M4 and M5 leukemia will participate in this study. Both decitabine and ribavirin have approval from the FDA but not when used in this combination for leukemia. The study will also look at the effects of the treatment on your leukemia and other cells in your blood and bone marrow. These studies will be done by researchers at the University of Rochester. As part of this study, blood and bone marrow samples may be frozen for experiments that cannot be done immediately but will only be used for studies that are related to this research study or to leukemia and other types of cancer.
Clinical trial: NCT02109744
Section: Voluntary Participation
Subsections: My Signature Agreeing To Take Part In The Study

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Subject's name (printed):______________________________________________
Subject's signature:___________________________________________________
Date of signature:__________________
Clinical trial: NCT02109744
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part In This Study?|May I Withdraw From The Study?|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
If your health changes and the study is no longer in your best interest If new information becomes available If you do not follow the study rules If the study is stopped by the sponsor, IRB or FDA.  
RSRB Approval Date: 8/1/2019

Yes. If you withdraw your permission to be in the study, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. Is my health information protected after it has been given to others? No. There is a risk that your information will be given to others without your permission.

If you decide you no longer want your samples to be used, you can call the study doctor, Dr. Jane Liesveld, at 585-275-4099 who will let the researchers know. Then, any sample that remains in the bank will no longer be used and related health information will no longer be collectd. Samples or related information that have already been given to or used by researchers will not be returned.