Clinical trial: NCT03160079
Section: Alternatives
Subsections: Alternatives To Participation

If you choose not to take part in or stop participating in this research study, there may be other treatments. Refusal to take part in this study will not cause penalty or loss of benefits to which you are otherwise entitled. You do not have to participate in this study to receive treatment for your cancer. Other possible treatments could include treatment with other drugs or drug combinations, or other research studies. Please talk to your doctor about these and other options. You do not have to participate in this study to receive blinatumomab. Blinatumomab (Blincyto) is commercially available. Please talk to your doctor about these and other options.
Clinical trial: NCT03160079
Section: Confidentiality
Subsections: Confidentiality

The confidentiality of your research records will be maintained to the extent allowed by law. This includes using locked filing cabinets and the use of passwords will be required to access your personal data on computers. Access to your information will be limited to study personnel who need to use it for the purpose of the research in this study. Only the minimum necessary information required will be collected, stored, used and reported. Your medical information will not be made publicly available unless disclosure is required by law or regulation.  
Data obtained from this study will be given to the sponsors of this study, Amgen, Inc, and Merck& Co, Inc, and/or its representatives, and may be published or given to regulatory authorities, including the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) agencies, the UCSD Institutional Review Board, the Moores UCSD Cancer Center Data and Safety Monitoring Board (DSMB) and other governmental agencies in the United States or other countries in which regulatory approval of pembrolizumab or blinatumomab may be sought. Your identity will remain confidential. Study data is labeled with a code instead of your name or other information that can easily identify you. You will be asked to sign a separate HIPAA authorization form to allow the study team to access and share information from your medical record. Your permission as described in this informed consent and HIPAA document does not have an automatic expiration date.
Clinical trial: NCT03160079
Section: Duration of Study Involvement
Subsections: Duration Of The Study **/ How Long Is Each Visit?**

The length of your participation in this study will be determined by how you react to the study drugs. The study will involve a screening period, drug period (up to 28 weeks), and a follow-up period where we will follow your condition for up to 4 years. Each of your study visits can last from approximately one to eight hours.
Clinical trial: NCT03160079
Section: Participant Responsibilities
Subsections: Procedures What Are My Obligations If I Take Part In This Study?

If you decide to take part in this study, you must be willing to do the following:
Attend the scheduled visits Tell the study staff about any other medicines that you are taking Tell the study staff about any side effects of the drugs that you experience
Clinical trial: NCT03160079
Section: Participant's Rights
Subsections: Signature And Consent|Experimental Subject'S Bill Of **Rights**

Your participation in this study is voluntary, and you may refuse to participate or withdraw from the study at any time without prejudice or loss of benefits to which you are otherwise entitled. You will receive a signed copy of this consent document and a copy of "The Experimental Subject's Bill of Rights" to keep. You agree to participate. ________________________________ Printed Name of Participant
_________________
Signature of Participant Date _________________________________ Printed Name of Person Obtaining Consent
__________________  
  
Signature of Person Obtaining Consent Date Human Research Protections Program University of California, San Diego
(858) 246-4777 9500 Gilman Drive, Mail Code 0052 (858) 246-3329 (FAX) La Jolla, CA 92093-0052

The faculty and staff of the University of California, San Diego wish you to know: Any person who is requested to consent to participate as a subject in a research study involving a medical experiment, or who is requested to consent on behalf of another, has the right to:
1. Be informed of the nature and purpose of the experiment.  
2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be used.  
3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.  
4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.  
5. Be given a disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.  
6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.  
7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved.  
8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and the subject may discontinue participation in the medical experiment without prejudice.  
9. Be given a copy of a signed and dated written consent form when one is required. 10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject's decision.
If you have questions regarding a research study, the researcher or his/her assistant will be glad to answer them. You may seek information from the Human Research Protections Program - established for the protection of volunteers in research projects - by calling (858) 246-4777 from 7:30 AM to 4:00 PM, Monday through Friday, or by writing to the above address.
Clinical trial: NCT03160079
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation|There Is Also The Potential For **Immune-Mediated Complications, Including Death, In Patients** Who Proceed To Allogeneic Hematopoietic Stem Cell Transplantation (Hcst) After Treatment With Pembrolizumab.|Additional Risks And Discomforts Associated With Study Procedures

Participation in this study may involve some added risks or discomforts. While you are on this study, you are at risk for the side effects listed below. You should discuss these with your doctor. There may also be other side effects that we cannot predict. Other drugs will be given to make side effects less serious and uncomfortable. Many side effects go away shortly after the study drug is stopped, but in some cases, side effects may be serious, long-lasting, and may even cause death. Possible side effects of specific drugs used in this study include:

Patients treated with pembrolizumab before going on to allogeneic stem cell transplant (a procedure in which a person receives blood-forming stem cells from a donor), should inform their transplant physicians that they have received pembrolizumab in the past. In patients with any hematologic malignancy (cancers of the blood like Hodgkin lymphoma, multiple myeloma): B-lineage acute lymphoblastic leukemia there is a potential for an increased risk of severe complications following allogeneic stem cell transplant in patients who previously received pembrolizumab before an allogenic stem cell transplant. Reports clotting of blood within the liver and severe graft versus host disease (which can include skin, liver and gastrointestinal symptoms), including death, have been received for patients who received pembrolizumab before an allogeneic stem cell transplant.

Risk of Testing for HIV: Participation in this study will require that you be tested for HIV. These tests are necessary to make sure that these study procedures would be appropriate for you. Testing for HIV may result in a diagnosis of infection with this virus. You will be informed of the results of these tests; if you do not wish to know the results, you should refuse to participate in this study. In the event that you are diagnosed with HIV, your doctor will give you the results in a face-to-face discussion (not by telephone or mail), counseling will be offered to you, and the results will be entered in your medical record and provided to the California State Board of Health. In the event that you are diagnosed with HIV, you may be referred to a doctor who specializes in these illnesses. The diagnosis of HIV may result in earlier treatment and/or prevention of many complications from the illnesses. Efforts will be made to keep your personal information confidential. Awareness of a diagnosis of these illnesses may have serious personal or social consequences. Some of these consequences include possible difficulty obtaining health insurance or employment, and difficulty traveling to some foreign countries.  
Allergic Reactions: As with any drug, there is the chance of an allergic reaction, which may include difficulty breathing, rash, flushing, weakness, dizziness, lightheadedness, and swelling. Intravenous (IV) Injection Side Effects: If the drug leaks from the vein, where the needle was inserted, it may cause skin irritation at the needle site and surrounding tissue. All injections into your vein can cause swelling, a burning sensation, tightness, bruising, bleeding, and/or nerve damage have a slight risk of pain, bleeding, infection, and rarely, fainting and/or nerve damage Risks of blood draws: There is a risk of discomfort or pain, bleeding, swelling and a small arm bruise and swelling when blood is drawn. Rarely, a clot or infection may occur at the site of the blood draw. Some people also become faint, dizzy, or light-headed during or immediately after the blood draw. Risks of bone marrow aspirate and biopsy: It is very painful when bone marrow is removed but pain will last only last 15 - 30 seconds. However, the area may be sore for a day or two. It is very rare, but you may have an allergic reaction to the numbing medicine; this reaction may include swelling in the throat, difficulty breathing, changes in heart rate or blood pressure, rashes or even death in rare cases. A large amount of bleeding or an infection are possible but are rare. Risks of lumbar puncture: There is a risk of headache and nausea, discomfort or pain in the back, bleeding and infection. Reproductive Risks: It is not known if blinatumomab is harmful to an unborn or breastfed baby. If you become pregnant during this study, potential risks could include complications such as miscarriage (loss of the pregnancy) or birth defects. In order to participate in the study you adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period. Non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive. Highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is ≥45 years of age and has not had menses for greater than 2 years will be considered postmenopausal), or 3) not heterosexually active for the duration of the study. The two birth control methods must be two barrier methods OR a barrier method plus a hormonal method to prevent pregnancy. If you are female, you should start using birth control from study Day 1 throughout the study period and for 120 days after the last dose of study therapy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents). You should not become pregnant or father a baby while on this study because the drugs in this study can affect a fetus and cause serious birth defects. Women should not breastfeed a baby while on this study and for 60 days after the last study treatment. It is important you understand that you need to use birth control while on this study. If you are female and capable of childbearing, a pregnancy test will be done before the study begins in order to be as sure as possible that you are not pregnant. Your participation requires that you use two contraception methods (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study. Ask about counseling and more information about preventing pregnancy. If you or your partner become pregnant while you are participating in this study, you must report it to your study doctor immediately. Dr. Wieduwilt will then ask for permission to follow what happens to during and after the pregnancy using a separate informed consent document. Risks from X-rays and/or Scans: During your participation in this research study, you will be exposed to radiation from scheduled x-rays and/or imaging scans. The total exposure resulting from these imaging studies is calculated to be 39.2-99.5 mSv, depending on which scans are required to adequately monitor your illness. This amount is more than you would receive from one year of natural exposure in the San Diego area, which is approximately 1.6 mSv. Cumulative exposure from radiation may increase your risk of developing certain types of cancer in the future. The principal investigator for this research study has determined and verified that all of the imaging scans prescribed for this study would typically be performed as part of the standard medical care required to adequately monitor your current illness. Scans are typically done as part of your standard care to assess your disease. If you are especially concerned with radiation exposure, or you have had a lot of x-rays or imaging scans already, you should discuss this with study doctor for this study, Dr. Wieduwilt, or your regular doctor.  
Risks of IV Contrast: As part of this study a CT scan may be done. There may be some reactions related to the contrast dye used in CT scans. Contrast dye is usually administered when you get a CT scan. Contrast dye may also be used in PET/CT scans and MRI scans. Some people may develop hives and itching or other allergic symptoms from this dye, swelling of the heart, cramps of the voicebox, breathing distress caused by narrowing of the airways in lungs, low blood pressure, with loss of consciousness, and in rare cases, severe loss of blood and fluids leading to shock and death, fainting, seizures, and irregular heartbeats. In addition, if you have low kidney function, this dye can temporarily or permanently decrease your kidney function. Risks of Loss of Confidential Information: There is also a small risk that information from your health records will be released to an unauthorized party. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small. An identification code assigned by the study team to each participant will be used in place of your name to protect your identity when reporting trial-related data. There may be other risks associated with participation in this study that are currently unforeseeable. You will be informed of any significant new findings.
Clinical trial: NCT03160079
Section: Procedures
Subsections: What Will Happen **If I Take Part In The Study?**|Screening Procedures|Study Procedures|Biological Samples

If you agree to participate in this study, you will have the following tests and procedures to see if you are an appropriate candidate to participate further in the study. These tests are called "Screening Procedures."

The Screening Visit (Visit \#1) may take between 2 and 8 hours to complete and the procedures may be scheduled over multiple days. Some of these may be part of your regular medical care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. Your study doctor will talk to you about these tests.  
1. You will be asked about your medical history, including previous cancer therapies. 2. You will be asked for your demographic information (date of birth, gender, race, and ethnicity).  
3. You will be given a physical exam and your weight, height and vital signs will be measured (your heart rate, blood pressure, and temperature).  
4. You will be asked about any medications you are taking or have taken in the past. 5. You will be asked questions about your health and how your disease affects your daily life. You will also be asked to fill out a brief questionnaire about your quality of life.  
6. Samples of your blood (approximately 2-3 tablespoons) will be drawn for laboratory tests:
o Hematology or CBC (Complete Blood Count), which includes: white blood cell count, red blood cell count, platelet count, hemoglobin (oxygen-carrying pigment in red blood cells), hematocrit (measures the amount of space red blood cells take
up in the blood). This is to aid in diagnosing anemia (low red blood cell count which can result in fatigue), certain cancers of the blood, and to monitor blood loss and infection.  
o Blood chemistry (which measures the levels of a number of chemical substances that are released from various tissues in the body to evaluate the function of the liver and kidneys).  
o Coagulation studies (a test to determine how quickly your blood clots).  
o Hepatitis screening: You will be informed of the results of the tests. The results of the tests, if positive, will be reported to the San Diego County health department as required by law and entered in your medical record. Your study doctor will discuss this with you
7. HIV testing is done to make sure that the study procedures are appropriate for you. If you test positive for HIV, the results must be entered in your medical record and provided to the California State Board of Health as required by law.  
8. A pregnancy test will be performed if you are a woman of child-bearing potential.  
Pregnant women cannot be on the study.  
9. You will have a chest X-ray. This test is performed by an x-ray technician. You will be asked to stand in front of the machine and must hold your breath when the x-ray is taken.  
10. You will have a CT (or PET) scan of your chest, abdomen and pelvis to measure your disease.  
o CT scan: The CT (computed tomography) scanner is a free-standing machine with a large hole in the center. You will be asked to lie on your back with your arms raised above your head on a narrow table that slides into the hole. Patients who have difficulty with enclosed spaces such as those found with some MRI scanners do not usually have a problem with this type of test. A dye may be injected into a peripheral vein to better evaluate certain diseases and organs. The radiologist will decide if this is necessary. Tell the technician or radiologist if you have any allergies or have had difficulty with prior CT scans. It is very important that you remain still throughout the exam and hold your breath when asked. This will allow for better images. The actual scan time is usually about two minutes, although the entire procedure usually takes much longer.  
o Positron Emission Tomography (PET scan). You will be taken into a special injection room, where the radioactive substance is administered as an intravenous injection (although in some cases, it will be given through an existing intravenous line or inhaled as a gas). It will then take approximately 30 to 90 minutes for the
substance to travel through your body and accumulate in the tissue under study. During this time, you will be asked to rest quietly and avoid significant movement or talking. After that time, scanning begins.  
11. You will have a bone marrow aspirate and biopsy. A bone marrow aspirate will be performed, usually before the biopsy is taken. The bone marrow sample is usually taken from the hip bone. The skin is cleansed, and a local anesthetic is injected to numb the skin. After the skin is numbed, the needle is inserted into the bone, and a syringe is used to withdraw the liquid bone marrow. You will feel a sting and slight burning sensation when the numbing medicine is applied. You may feel pressure as the needle is inserted into the bone, and a sharp and sometimes painful sucking sensation as the marrow is removed. This feeling lasts for only a few moments. The needle will be removed and either repositioned, or another needle may be used for the biopsy. The biopsy needle is then inserted into the bone. The core of the needle will be removed, and the needle is pressed forward and rotated in both directions. This forces a tiny sample of the bone marrow into the needle. The needle is then removed. Pressure is applied to the biopsy site to stop bleeding, and a bandage is applied. The biopsy needle may also cause a brief, usually more dull, pain. However, not all patients have such pain.  
If the exams, tests and procedures show that you can be in the study and you choose to take part, you will receive the study drugs.

At each study visit you will be asked about any current symptoms, whether you have had any side effects, and if there have been any changes to the medications you take since the last visit. On day 29 during cycles 1 through 4 and day 38 of cycle 5 you will have a lumbar puncture (spinal tap) with intrathecal (delivered with a needle directly into the fluid surrounding your spinal cord) methotrexate. In this study you will have a total of 6 doses, including the dose given at screening.  
| Cycle 1 - Hospital admission required day 1-9  Day 1  Get physical exam and routine blood tests.  Receive dexamethasone IV once 1 hour before start of infusion  Start IV infusion of blinatumomab for days 1-7  Have a sample of blood taken to measure drug levels. Day 2-3  Have a sample of blood taken to measure drug levels.   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| Day 8                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                             | Receive dexamethasone IV once 1 hour before start of infusion   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Start IV infusion of blinatumomab for days 8-28                                              |                                                                 |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Have a sample of blood taken to measure drug levels.                                         |                                                                 |
| Day 9-10                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                             | Have a sample of blood taken to measure drug levels.            |
| Day 14                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                             | Get routine blood tests                                         |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies. |                                                                 |
| Day 15                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                             | Have a sample of blood taken to measure drug levels.            |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Receive IV infusion of pembrolizumab.                                                        |                                                                 |
| Day 16-17                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                                                                                             | Have a sample of blood taken to measure drug levels.            |
| Day 21                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                             | Have a sample of blood taken to measure drug levels.            |
| Day 29                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                             | Get routine blood tests                                         |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies. |                                                                 |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | May have an imaging scan (CT or PET) of your chest, abdomen and  pelvis                      |                                                                 |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Have a lumbar puncture with methotrexate.                                                    |                                                                 |
| Day 36                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                             | Get routine blood tests                                         |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | Receive IV infusion of pembrolizumab.                                                        |                                                                 |
| Cycle 2 - Hospital admission required day 1-2 Day 1  Get routine blood tests  Receive dexamethasone IV once 1 hour before start of infusion  Start IV infusion of blinatumomab for days 1-28 Day 15  Get routine blood tests  Receive IV infusion of pembrolizumab. Day 29  Get routine blood tests  Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies.  May have an imaging scan (CT or PET) of your chest, abdomen and  pelvis  Have a lumbar puncture with methotrexate. Day 36  Get routine blood tests  Receive IV infusion of pembrolizumab Cycle 3 and 4 |                                                                                              |                                                                 |  
| Day 1                   |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|-------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----|----|-------------------------|
|                        | Receive dexamethasone IV once 1 hour before start of infusion                                |                                                                                              |    |    |                         |
|                        | Start IV infusion of blinatumomab for days 1-28                                              |                                                                                              |    |    |                         |
| Day 15                  |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Receive IV infusion of pembrolizumab.                                                        |                                                                                              |    |    |                         |
| Day 29                  |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies. |                                                                                              |    |    |                         |
|                        | Have an imaging scan (CT or PET) of your chest, abdomen and pelvis                           |                                                                                              |    |    |                         |
|                        | Have a lumbar puncture with methotrexate.                                                    |                                                                                              |    |    |                         |
| Day 36                  |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Receive IV infusion of pembrolizumab.                                                        |                                                                                              |    |    |                         |
| Cycle 5 Day 1           |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Receive dexamethasone IV once 1 hour before start of infusion                                |                                                                                              |    |    |                         |
|                        | Start IV infusion of blinatumomab for days 1-28                                              |                                                                                              |    |    |                         |
| Day 15                  |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Receive IV infusion of pembrolizumab.                                                        |                                                                                              |    |    |                         |
| Day 36                  |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Receive IV infusion of pembrolizumab.                                                        |                                                                                              |    |    |                         |
| Day                     | 38                                                                                           | (End                                                                                         | of |   | Get routine blood tests |
| Treatment Visit)        |                                                                                             | Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies. |    |    |                         |
|                        | Have an imaging scan (CT or PET) of your chest, abdomen and pelvis                           |                                                                                              |    |    |                         |
|                        | Have a lumbar puncture with methotrexate.                                                    |                                                                                              |    |    |                         |
| End of Treatment Day 38 |                                                                                             | Get routine blood tests                                                                      |    |    |                         |
|                        | Have a bone marrow aspirate and biopsy. An extra sample will be  taken for research studies. |                                                                                              |    |    |                         |
|                        | Have an imaging scan (CT or PET) of your chest, abdomen and  pelvis                          |                                                                                              |    |    |                         |
|                        | Have a lumbar puncture with methotrexate.                                                    |                                                                                              |    |    |                         |
| Every 3 months until    |                                                                                             | Get physical exam and routine blood tests.                                                   |    |    |                         |  
| discontinuation of  trial participation.   |
|--------------------------------------------|  
Upon discharge from the hospital, your coordinator will arrange infusion center appointments to ensure that you continue receiving blinatumomab. You will continue receiving blinatumomab while using an ambulatory infusion pump and will come in to the infusion center for IV bag changes. A participation information sheet and instructions about your infusion pump will be provided to you in a separate document.

As described in the study Procedures above, blood samples will be collected from you throughout the study. Additional research samples will also be collected throughout the study. Bone marrow will be collected with your standard of care bone marrow and sent to a central reader for evaluation of specific biomarkers (biological properties or molecules that can be detected and measured in parts of the body like the blood or tissue. These biomarker samples will be collected at screening, cycle 1 day 14, cycle 1 day 38-42, cycle 2 day 38-42, cycle 5 day 38-42, and relapse (if applicable). Serum cytokines will also be collected from peripheral blood on days 1, 2, 3, 8, 9, 10, 15, 16, 17, and 21 of cycle 1. These samples will be analyzed for biomarkers that might help determine which patients have a higher or lower likelihood of responding to pembrolizumab and blinatumomab. There will be no direct benefit to you from this testing since you will not be provided with any results or information regarding the testing of your sample. Samples will be sent to the UCSD Lab of Gerald Morris, MD, PhD. They will be stored until the study is completed and batch analysis of the samples can be performed.  
Dr. Matthew Wieduwilt will be responsible for deciding how your samples will be used. Blood/Bone marrow taken from you may be used to establish products that could be patented and licensed. There are no plans to provide you with financial compensation should this occur. Your blood/bone marrow may also be used in additional research to be conducted by the University of California personnel and the group collaborating in this research, Amgen Inc and Merck, Inc. Biospecimens (such as blood, tissue, or saliva) collected from you for this study and/or information obtained from your biospecimens may be used in this research or other research, and shared with other organizations. You will not share in any commercial value or profit derived from the use of your biospecimens and/or information obtained from them. If you decide later that you do not want the specimens collected from you to be used for future research, you may tell this to Dr. Matthew Wieduwilt, who will use his best efforts to stop any additional studies. However, in some cases, such as if your samples have already been tested, the data from these tests are no longer linked to your identity and cannot be removed from the research database Federal and State laws generally make it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
a) Health insurance companies and group health plans may not request your genetic information that we get from this research. b) Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. c) Employers with 5 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.  
Be aware that these laws **do not** protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Clinical trial: NCT03160079
Section: Purpose of Research
Subsections: Purpose

The purpose of the study is to investigate the safety of the drug combination pembrolizumab (also known as MK-3475) and blinatumomab, and to determine whether this combination has an effect on your cancer and body. Blinatumomab is a standard treatment for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Pembrolizumab is a type of drug called an immunomodulatory drug. This drug is approved by the United States (U.S.) Food and Drug Administration (FDA) as a treatment for unresectable (cannot have surgery) or metastatic (the cancer has spread to other parts of the body) melanoma. Pembrolizumab is considered experimental because it is not approved by the FDA for the treatment of B-cell ALL. Participation in this study is entirely voluntary. A total of 24 participants will take part in this multi-center study. Approximately 6 participants will be enrolled at UC San Diego.
Clinical trial: NCT03160079
Section: Voluntary Participation
Subsections: Voluntary Participation

Participation in this study is entirely voluntary. If you choose not to participate or wish to withdraw your consent to participate in these study procedures at any time, it will in no way affect your regular treatments or medical care at this institution or loss of benefits to which you are entitled. Please contact Dr. Matthew Wieduwilt or a member of his/her study team if you wish to withdraw from participation. You will be informed of any new findings that might affect your willingness to continue participating in the study. If health conditions occur which would make your participation in this study possibly dangerous, or if other conditions occur that would make participation in this study detrimental to you or your health, then your study doctor may discontinue your participation in this study.