UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM CONSENT TO PARTICIPATE IN A LONG TERM FOLLOW UP TO A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION

Transcription

1 UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM CONSENT TO PARTICIPATE IN A LONG TERM FOLLOW UP TO A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION Protocol No. VRX496-USA LTFU: Long-term Follow-up of Subjects Exposed to Lentiviral-Based Gene Therapy for, VRX496-USA or VRX496-USA Rollover protocols Study Sponsor VIRxSYS Corporation Principal Investigator Pablo Tebas, MD Study Coordinator Joseph Quinn, RN, BSN Clinical Site University of Pennsylvania Site Address 502 Johnson Pavilion Division of Infectious Diseases Philadelphia, PA Telephone Contact: Introduction: You previously enrolled/completed in a VIRxSYS sponsored clinical trial entitled; A Phase I Clinical Trial of the Safety and Tolerability of a Single Dose of Autologous T Cells Transduced with VRX496 in HIV Positive Patient-Subjects. Participants enrolled in two other studies (A Phase II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Biological Activity of Single and Repeated Doses of Autologous T Cells Transduced with VRX496 in HIV-Positive Subjects or a rollover study,a Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA trial with Autologous T Cells Transduced with VRX496) may also enroll in this follow up study. Prior to enrolling in these studies, you signed an Informed Consent Form, agreeing to participate in the study including long-term follow-up for safety evaluation for fifteen years. As was explained in the original consent form, long-term follow-up is part of a safety evaluation that the FDA requires for all gene therapy trials using retroviral vectors such as the one used in the trial(s) you enrolled in. Since the long-term follow-up visit schedule and safety tests are identical in the above three protocols, and in order to facilitate ease of safety data collection, a new protocol has been written that specifically identifies visit schedules and type of clinical testing required by the FDA for evaluation of long-term safety outcomes. Since these studies opened at different time points, participants will have completed varied lengths of follow up at the time they enter this long term follow up. This Informed Consent Form contains information that was previously discussed with you when you first enrolled in the trial(s). The information is reiterated here for your convenience. After reading this informed consent, you will be asked to sign this form, and a copy will be given to you for your records. Why am I being asked to volunteer? You are being invited to continue to participate in the follow-up portion of the research study because you received at least one infusion of Lexgenleucel-T. Your participation is voluntary, which means you can choose whether or not you want to participate. If you choose not to re-consent there will be no negative effect on you. However, prior to making your decision, please refresh your 1

2 memory as to what requirements are expected of you. If you find that some of the medical language is difficult to understand, please ask the study doctor and/or research team about this form. How long will I be in this study? The study will continue for up to 15 years. However, requirements for physically reporting at the study clinic (i.e. at the center where you received your infusion) will depend on the following: You are required to visit the clinic to complete the semiannual and annual visits during the first 5 years of the study as outlined in Table 1 Once study drug is no longer detected in your blood for two consecutive visits, you will no longer be required to report to the clinic for the semiannual visits. However; you will still be required to report for the annual visits through year 5. If no study drug is detected in your circulation at the 5 year visit, you do not have to report to the clinic. Instead, you will be contacted annually by phone or mail. If study drug is detected in your blood at the end of your Year 5 visit, then you will continue to be followed in the clinic every year until the drug is no longer detected in your blood. The study team may bank (store) samples from some of your blood throughout your participation in this study. These samples will be kept frozen and will not identify you by name. Table 1: Summary of visits and evaluations for the first 5 years of the study Year 1 Medical History, Physical Examination, list of medications Blood drawn (approximately 3 tablespoons) for routine blood tests, to Year 1.5 You will be asked about your most recent HIV viral load results and CD4+ cell counts, as well as any changes in your HIV medications, and side effects Blood drawn (approximately 1 tablespoon) for routine blood tests, to Year 2 Physical Examination, list of medications Blood drawn (approx 3 tablespoons) for routine blood tests, to evaluate Chemistries, Hematology, HIV viral load test, CD4+ and CD8+ cell counts and to determine if study drug is present in your body Year 2.5 You will be asked about your most recent HIV viral load results and CD4+ cell counts, as well as any changes in your HIV medications, and side effects Blood drawn (approximately 1 tablespoon) for routine blood test to determine if study drug is present in your body Year 3 Physical Examination, list of medications Blood drawn (approximately 3 tablespoons) for routine blood tests, to Year 3.5 You will be asked about your most recent HIV viral load results and CD4+ cell counts, as well as any changes in your HIV medications, and side effects Blood drawn (approximately 1 tablespoon) for routine blood test to determine if study drug is present in your body 2

3 Year 4 Physical Examination, list of medications Blood drawn (approximately 3 tablespoons) for routine blood tests, to Year 4.5 You will be asked about your most recent HIV viral load results and CD4+ cell counts, as well as any changes in your HIV medications Blood drawn (approximately 1 tablespoon) for routine blood test to determine if study drug is present in your body Year 5 Physical Examination, list of medications Blood drawn (approximately 3 tablespoons) for routine blood tests, to Participants enrolled at the University of Pennsylvania have all passed the Year 5 milestone in the original parent study. No participants have any measurable level of the study product at Year 5. Thus no visits to the clinic site for follow up are required. You will continue to be seen for years 7 to 15 through this protocol. Table 2: Summary of visits and evaluations for Year 6 up to Year 15 if study drug is detected in your blood Year 6 to Year 15 if study drug is detected in your blood Table 3: Physical Examination, list of medications Blood Tests (approximately 1 tablespoon) to determine if study drug is in your body and samples may be banked Summary of subject contact for Year 6 up to Year 15 if study drug is not detected in your blood Year 6 to Year 15 if study drug is no longer detected in your blood (one contact per year) No site visit/examination Via questionnaire, you will be asked about your most recent doctor s visit, your most recent HIV viral load results and CD4+ cell counts as well as any changes in your condition since last visit When you enroll in this long term follow up, the study team would like you to identify a your health care provider so they can be sent a letter regarding your participation in this long term follow up and to ask them for assistance in reporting information regarding your health. You will be provided a copy of this letter. 3

4 What are the possible risks or discomforts for being in this study? Below are possible risks associated with participation in this long-term follow-up study: Risks associated with blood draws: Drawing blood involves a small puncture in your skin. Risks associated with this procedure are minimal, but blood drawing may cause bruising, pain, or infection at the site. Rarely, inflammation or irritation of the vein may occur. Potential risks associated with retroviral gene therapy (Lexgenleucel-T falls into this category) This section was included in your original Informed Consent Form and is presented here as a refresher for you, since there is a possibility of a delayed reaction to study treatment that you received. Please note, since you have already been infused with VRX496, there is no additive risk for enrolling in this long-term follow-up study. The main study involved giving a subject some cells that have been changed by a retroviral vector. A retroviral vector is a virus that can insert genetic material into cells. When retroviral vectors enter a normal cell in the body, the deoxyribonucleic acid (DNA) of the vector inserts itself into the normal DNA in that cell. This process is called DNA integration. Most DNA integration is expected to cause no harm to the cell or to the subject. However, there is a chance that DNA integration might result in abnormal activity of other genes. In most cases this effect will have no health consequences. However, there is a chance that there may be some regions of the normal human DNA where insertion of VRX496 DNA may result in activation of neighboring genes. For example, if the VRX496 attaches to a place that tells your body to start growing a cell, this may cause uncontrollable growth of the cell, resulting in cancer. We do not know if the retroviral vector used in this protocol might cause a new cancer. However, you should be aware that the DNA contained in retroviral vectors will blend into your DNA and that under some circumstances this has been known to cause malignant (cancerous) growth months to years later. It is important that you know about some cancers that occurred in another gene therapy research study. A study, conducted in France, was associated with a disease called X-linked Severe Combined Immunodeficiency (SCID). Years after receiving cells that were modified by a retroviral vector, a significant number of the children in this small study developed a leukemia-like malignant disease (cancer). At least one child died from the cancer. A group of experts in this field studied the results from tests performed on these children s blood cells. They concluded that the leukemia-like malignancy was caused by the retroviral vector DNA. However, most of the children with X-linked SCID who have received experimental gene therapy have not been found to have a leukemia-like disease at this time. Although they appear healthy, we still do not know whether they, too, will develop a malignant growth. Reporting of Adverse Events: The FDA has mandated that special attention be paid to the following events: 1. You have been diagnosed with any type of cancer, including blood disorders such as leukemia or lymphoma. 2. You develop loss of feeling in any part of your body, especially hands and feet: you develop a loss of control of any body parts (arms, legs); you have a seizure, you experience memory loss. In 4

5 addition, if you experience a worsening of any of the symptoms listed above, please contact your study doctor, nurse or primary care doctor. These types of symptoms are called neurological disorders. If your primary doctor tells you that you have developed neurological symptoms, you will need to contact the study doctor/nurse. 3. You develop arthritis or autoimmune disease, or worsening of previously experienced arthritis or autoimmune diseases, which you were experiencing prior to participation in the main study, contact your study doctor/nurse. If any of these events occur you must report them immediately to your study doctor/nurse or primary doctor. What are the possible benefits of the study? You may receive no benefit from taking part in this study. Information learned from this study may help others who have HIV/AIDS. Will I be paid for being in this study? For your clinic visit today to consent to the follow up study, you will receive $20 to cover costs for transportation and time spent. You will also be paid a $10 for completing the questionnaires that will be sent by mail or dictated to you by phone. What about confidentiality? If you consent to participate in this study, your signature provides permission for your medical records to be directly accessed and reviewed by authorized individuals from VIRxSYS Corporation or VIRxSYS Corporation representatives, the study team, by regulatory authorities such as the FDA, or by the Institutional Review Board (IRB). The purpose of reviewing the records is to ensure the information collected for this research study is accurate and that the study protocol has been carried out correctly. Records, which reveal your identity, will be kept confidential by these parties. However, in rare instances, revealing your identity to another party may be required by law. Information from the study may be published, but this will not include your name or any identifying markers. HIPAA AUTHORIZATION The authorization part of the consent gives more detailed information about how your personal health information may be used and disclosed by the University of Pennsylvania Health System (UPHS), the School of Medicine and the individual Principal Investigator, subject to University of Pennsylvania procedures. What personal health information is collected and used in this study and might also be disclosed? The following personal health information will be collected, used for research, and may be disclosed during your involvement with this research study: 5

6 Name, address, telephone number, date of birth Personal and family medical history Current and past medications or therapies Information from questionnaires administered in the study Why is your personal contact and health information being used? Your personal contact information is important for the research team to contact you during the study. Your personal health information and results of tests and procedures are being collected as part of this research study. In some situations, your personal health information might be used to help guide your medical treatment. Which of our personnel may use or disclose your personal health information? The following individuals may use or disclose your personal health information for this research study: The Principal Investigator and the Investigator s study team Authorized members of the workforce of the UPHS and the School of Medicine, and University of Pennsylvania support offices, who may need to access your information in the performance of their duties (for example: for research oversight and monitoring, to provide treatment, to manage accounting or billing matters, etc.). Who, outside of UPHS and the School of Medicine, might receive your personal health information? As part of the study, the Principal Investigator, the study team and others listed above, may disclose your personal health information, including the results of the research study tests and procedures. This information may be disclosed to those listed below: Individuals or organizations responsible for administering the study: - VIRxSYS Corporation: This is the sponsor of the study who supplied the study drug in the parent study Regulatory and safety oversight organizations The Food and Drug Administration The Office of Human Research Protections Once your personal health information is disclosed to others outside of UPHS or the School of Medicine, it may no longer be covered by federal privacy protection regulations. Data are reported to the sponsor on Case Report Forms that identify you by your unique study number and not your name, date of birth or medical record number. Information regarding your health, such as side effects of the study drug you experience will be reported only by code number. All samples collected for analysis will be labeled with your study number, visit number and date of your visit. The Principal Investigator or study staff will inform you if there are any additions to the list above during your active participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed to protect your privacy. 6

7 How long may UPHS and the School of Medicine be able to use or disclose your personal health information? Your authorization for use of your personal health information for this specific study does not expire. Your information may be held in a research database. However, the School of Medicine may not reuse or re-disclose information collected in this study for a purpose other than this study unless: You have given written authorization The University of Pennsylvania s Institutional Review Board grants permission As permitted by law Can I change my mind about giving permission for use of my information? Yes. You may withdraw or take away your permission to use and disclose your health information at any time. You must do so in writing to the Principal Investigator at the address on the first page. Even if you withdraw your permission, your personal health information that was collected before we received your written request may still be used and disclosed, as necessary for the study. If you withdraw your permission, you will not be able to stay in this study. 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. What are my rights as a research subject? Taking part in this study is completely voluntary. You may choose not to take part in this study, or leave this study at any time. You will be treated the same no matter what you decide. What happens if I am injured? In the event of any injury resulting from your participation in this study, immediate medical treatment will be provided to you. VIRxSYS will pay for reasonable costs of medical treatment for the injury, except for costs that are covered by your medical insurance, hospital insurance, third party payers, or governmental programs. No other compensation will be offered by VIRxSYS. You are not waiving any of your legal rights to seek additional compensation through the courts. CONSENT When you sign this form, you are agreeing to take part in this research study. This means that you have read the consent form, your questions have been answered, and you have decided to volunteer. Your signature also means that you are permitting the University of Pennsylvania Health System and the School of Medicine to use your personal health information collected about you for research purposes within our institution. You are also allowing the University of Pennsylvania Health System and the School of Medicine to disclose that personal health information to outside organizations or people involved with the operations of this study. I have read the informed consent form (or it has been read to me), this study has been explained to me, and I have had the opportunity to ask questions. All of my questions have been answered to my satisfaction. 7

8 My participation is voluntary and I may refuse to participate at any time with no penalty or loss of benefits to which I am entitled. I am free to withdraw at any time. I agree to participate in this research study. I authorize the use and disclosure of my health information to the parties listed in the authorization section of this consent for the purposes described above. By signing this consent form, I have not given up any of my legal rights. Name of Subject Signature of Subject Date Name of Person Conducting Signature of Person Conducting Date Informed Consent Discussion the Informed Consent Discussion If you agree to have an autopsy at time of your death, whenever that should occur, please check the yes box and sign below. If you do not agree, check the no box and sign below. You can change your mind at any time and update this permission. Yes No Signature Date 8

9 Use the following only if applicable If this consent form is read to the subject because the subject is unable to read the form, an impartial witness not affiliated with the research or investigator must be present for the consent and sign the following statement: I confirm that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject. The subject freely consented to be in the research study. Name of Impartial Witness Signature of Impartial Witness Date Note: This signature block cannot be used for translations into another language. A translated consent form is necessary for enrolling subjects who do not speak English. 9