Clinical trial: NCT00984165
Section: Alternatives
Subsections: Alternative Approaches

If you choose not to enroll in this research study, you will still receive all planned therapy under your primary treatment protocol. Information about your immune system, tissue samples from any biopsies you have had or will have, and subsequent treatment response or GVHD after DLI treatment will not be evaluated under this protocol.  
STUDY NUMBER: 09-C-0224 CONTINUATION: page 4 of 8 pages
Clinical trial: NCT00984165
Section: Participant's Rights
Subsections: Research Subject'S Rights

What are the costs of taking part in this study?  
If you choose to take part in the study, the following will apply, in keeping with the NIH policy:
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs even if they are not covered by your insurance company.  
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 09-C-0224 CONTINUATION: page 6 of 8 pages
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.  
Participation in this research study is voluntary. You may discontinue your participation at any time. You will be given a  
 copy of the consent for your records. There are no penalties imposed for withdrawing from the research study. You may ask questions of the staff, and indeed are encouraged to do so.
Clinical trial: NCT00984165
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation

Donor Lymphocyte Infusion DLI Control Subjects will receive a donor lymphocyte infusion (DLI). The major risk of DLI is GVHD, described in detail below. Like the cells you received at the time of your transplant, the DLI are frozen with a chemical called DMSO to protect them from the effects of freezing. Patients receiving thawed cells often develop side effects from the DMSO. DMSO side effects may include fever and allergic reactions, such as skin rash, itching, difficulty breathing, and low blood pressure. These reactions are usually mild and temporary, and they can be easily treated with IV fluids and medications.  
Graft-Versus-Host Disease (GVHD)
Early (acute) GVHD, which generally occurs in the first 100 days after transplantation, sometimes occurs (in about onethird of patients) after DLI. Mild acute GVHD (skin rash only) can be treated with steroid lotions that you can apply on your skin. More severe acute GVHD can cause blistering of the skin, abdominal pain and diarrhea, disturbances in liver function and jaundice (yellowing of the skin) and require stronger treatment including steroids, which are given intravenously (through the vein). Occasionally, severe acute GVHD can be fatal.  
Delayed or chronic GVHD may also occur. Typically occurring after the first 100 days following transplantation, it also can occur after DLI. The risk of chronic GVHD seems to be about the same as the risk for acute GVHD, and about one-third of patients treated with DLI may develop chronic GVHD. Symptoms include dryness of the mouth and eyes, skin rash, joint stiffness, weight loss, liver damage (including jaundice), and lung damage leading to cough and shortness of breath. This is treated with drugs that suppress the immune system, such as cyclosporine and steroids given by mouth. Chronic GVHD can at times be present for the rest of your life. Both acute and chronic GVHD, and the drugs we use to treat them, can place patients at significant risk for infections, which can be life threatening, and even cause death. In patients whose tumors shrink after DLI, the risk of acute and chronic GVHD appears to be higher. About half of the patients whose tumor responds after DLI also develop some GVHD. You will be carefully monitored for any signs of new or worsening GVHD. If you develop GVHD, you will receive treatment as soon as possible in an attempt to limit its severity. Blood Sampling: Side effects of repeated blood sampling include pain and bruising in the area where the blood was drawn, lightheadedness, or rarely, fainting. If you have too much blood taken over a prolonged period, your red blood cell count may drop (this is called "anemia"). However, the amount of blood you will donate (a total of approximately 100 ml or 20 teaspoons) is not going to make you anemic if you have normal production of red blood cells. As a precaution, we will check your red blood cell level, and give you iron treatment if this is indicated. If you take "over-the-counter" medications, such as aspirin, Advil (ibuprofen), or naproxen, it is important to tell your physician and stop these at least 72 hours prior to the apheresis procedure.  
Apheresis: The most common side effects of the apheresis procedure include pain and bruising at the IV sites. You may experience fleeting low blood pressure during the apheresis procedure; if this occurs, the settings on the apheresis machine can be modified to treat this problem. Other side effects include chills, numbness and tingling sensations ("pins and needles") of your mouth, fingers, and toes, anxiety, mild muscle cramps, and nausea; these side effects are due to the anti-coagulant (blood thinner) used to prevent your blood from clotting while you are on the apheresis machine. More serious, although uncommon side effects due to the blood thinner lowering your calcium levels include: low blood pressure, seizures, weakness and muscle spasms. These discomforts can be treated with calcium (Tums) by mouth or by stopping the procedure. After the donation, it is common to experience a fleeting drop in your platelet count. Platelets help your blood to clot; however, it is highly unlikely that your platelet count would drop low enough from this procedure to be harmful.  
STUDY NUMBER: 09-C-0224 CONTINUATION: page 5 of 8 pages Intravenous Catheter Placement: Side effects of placing a temporary intravenous catheter in your femoral vein in your groin (if this is required), include bleeding, bruising, blood clot, infection, or pain in the area of insertion. This catheter will be placed by physicians with experience in this procedure; the above risks will be discussed by these physicians at the time of the catheter insertion. A separate consent form will be used if a femoral catheter is necessary.
Clinical trial: NCT00984165
Section: Voluntary Participation
Subsections: Consent To Participate In A Clinical Research Study Medical Record - Adult Patient Or - Parent, For Minor Patient|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study

INSTITUTE: National Cancer Institute STUDY NUMBER: 09-C-0224 PRINCIPAL INVESTIGATOR: Nancy M. Hardy, M.D. STUDY TITLE: Pilot Study of Radiation-Enhanced Allogeneic Cell Therapy for Progressive Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation Continuing Review Approved by the IRB on 05/13/13 Amendment Approved by the IRB on 12/13/11 (C) Date Posted to Web: 06/01/13 DLI Control

STUDY NUMBER: 09-C-0224 CONTINUATION: page 3 of 8 pages performed by trained personnel in the NIH Department of Transfusion Medicine, it is not considered experimental, however, the comparison that will be made between the immune cells in your relative's blood and tumor to the immune cells that remain in your blood is considered research. Apheresis requires two needlesticks to temporarily place catheters (plastic tubes) into veins in each arm. On rare occasions the veins in your arms may not be adequate to place the catheters. In that case a temporary catheter will be placed in a vein in your groin area. This catheter would be removed after your immune cells are collected. The apheresis procedure typically requires less than two hours of collection. These stem cell collections will be processed and frozen, but they will be used for research rather than given to your sibling. To donate cells by apheresis, you must be in generally good health. You must not have any personal medical history of psychiatric disorder, stroke, myocardial infarction (heart attack), or severe heart disease. If you are a woman, you will undergo a urine or blood test for pregnancy. Because of health risks to the fetus or baby, pregnant or lactating women will not be allowed to participate on this study. On your next visit to the NIH Clinical Center, you will be seen by a physician and other members of the NCI transplant team. This visit can be coordinated with the collection date. The doctor will take your medical history, perform a physical exam, and explain the procedure. Additional tests will be performed on your blood to determine the health of your kidneys and liver, your ability to clot your blood, your blood levels, and your blood type. You will also have blood draws to look at your immune cells before DLI, and three, seven and 14 days after DLI. Between two and five teaspoons of blood will be collected at these times. A maximum of 99 people (46 patients, 38 donors and 15 control participants) will be enrolled in this research study. Birth Control If you are a woman who is breast feeding or pregnant, you may not take part in the study because we don't know how this medicine would affect your baby or your unborn child. If you are a woman who can become pregnant, or are the partner of a woman who can become pregnant, you will need to practice an effective form of birth control when you enroll on this study and remain on birth control until you have completed the apheresis procedures. If you think that you or your partner is pregnant, you should tell your study doctor or nurse at once.  
Effective forms of birth control include:
- Abstinence
- intrauterine device (IUD)
- hormonal [birth control pills, injections, or implants]  
- tubal ligation
- vasectomy