Clinical trial: NCT02898259
Section: Confidentiality
Subsections: Hipaa Authorization Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to Brian Hill, MD, PhD or Paolo Caimi, MD and the research study staff at Cleveland Clinic and/or University Hospitals for the purposes of this research and to Case Western Reserve University for administration.  
The PHI that we may use or disclose (release) for this research may include your name, address, phone number, date of birth, Social Security number, information from your medical record, lab tests, or certain information relating to your health or condition.. Some of the tests and procedures done solely for this research study may also be placed in your medical record so other doctors know you are in this study.  Upon completion of the study, you may have access to the research information that is contained in your medical record.  
In addition to the investigators and research staff listed above, your PHI may be looked at by other groups involved with the study such as the Cleveland Clinic Institutional Review Board, University Hospitals Institutional Review Board and the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee.  Your PHI may also be used by and/or disclosed
(released) to:  
.  
.  
. .  
Case Comprehensive Cancer Center members and collaborators The Food and Drug Administration; The Department of Health and Human Services; The National Cancer Institute (NCI);
Other Institutional Review Boards; Data Safety and Monitoring Boards;
Once your personal health information is released it may be re-disclosed and no longer protected by privacy laws.  
Your research information may be used and disclosed indefinitely, but you may stop these uses and disclosures at any time by writing to:  
| Paolo Caimi, MD                          | or                               | Brian Hill, MD, PhD   |
|------------------------------------------|----------------------------------|-----------------------|
| Case Comprehensive Cancer Center         | Case Comprehensive Cancer Center |                       |
| University Hospitals Case Medical Center | Cleveland Clinic                 |                       |
| 11100 Euclid Ave.                        | 9500 Euclid Ave.                 |                       |
| Cleveland, OH 44106                      | Cleveland, OH 44195              |                       |  
Your participation in the research will stop, but any information previously recorded about you cannot be removed from the records and will continue to be used as part of this research.  Also, information already disclosed outside the Cleveland Clinic and/or University Hospitals cannot be retrieved.  This will not affect your rights to treatment or benefits outside the research study.  
The Cleveland Clinic and/or University Hospitals will not use your information collected in this study for another research purpose without your written permission; unless the Cleveland Clinic Institutional Review Board (IRB) and/or University Hospitals Institutional Review Board assures your privacy and confidentiality is protected.  The IRB is a committee whose job it is to protect the safety and welfare of research subjects.  
By signing this informed consent form, you are authorizing such access to your research and medical record information.  If you choose not to sign this consent form, you will not be able to participate in this research study.  This Authorization does not have an expiration date.
Clinical trial: NCT02898259
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

You will receive treatment with Ixazomib, lenalidomide and rituximab for one year. After you finish treatment, your doctor will check your response in 2-3 months and then continue to follow up with you for up to five years.  
What extra tests and procedures will I have if I take part in this study?  
All of the exams, tests, and procedures you will have are part of the usual approach for your cancer.  
Extra tubes of blood (about 2 teaspoons) will be drawn, at the same time other blood is drawn so there will be no extra needle sticks, at 3 times during the study: before treatment, after cycle 6 and at the end of treatment, to measure the number of different types of T cell lymphocytes in your blood. We will examine whether these T cell numbers help tell us who will respond best to the treatment. This same blood will also be tested for the number of B lymphocytes in your blood to see if this blood test can be a marker of how well the treatment has worked.
Clinical trial: NCT02898259
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Side Effects Of Rituximab: Common, Some May Be Serious In 100 People Receiving Rituximab. More Than 30 And Up To 100 May Have:

| In 100 people receiving rituximab. more than 30 and up to 100 may have:   |
|---------------------------------------------------------------------------|
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Clinical trial: NCT02898259
Section: Procedures
Subsections: What Are The Study Groups?

All patients will receive standard dosing of lenalidomide and rituximab. Ixazomib will be given at the maximally tolerated dose as determined by Phase I of the study which was 4.0 mg This study will use treatment cycles that are 28 days long. During the first cycle you will have a study visit once a week for 3 times. This is for Rituximab infusion on days 1, 8 and 15. You will also have an appointment for blood tests (and a pregnancy test if you are a woman who could become pregnant) on day 22. After cycle 1, treatment with Rituxumab will be administered on day 1 of cycles 2-6, 8, 10 and 12. The first time you are treated with Rituximab, the infusion will take about 6 hours. If you do not have any reactions, the next infusion can be reduced to about 4 hours. In later cycles the infusion can be further reduced to about 2 hours.  
You will take Ixazomib pills. The pills will be dispensed to you by the pharmacy. These should be taken by mouth once a week for 3 weeks, on days 1, 8 and 15 of every cycle You will take Revlimid pills. These will be sent to your home. You should take one of these  a day, every day for 3 weeks starting on day 1 of each cycle (so on days 1 through 21), and then not take them for the next  7 days (days 22 through 28).
Clinical trial: NCT02898259
Section: Purpose of Research
Subsections: Questions About The Research

If you have any questions, you can ask the Principal Investigator and/or research staff at (216)444-9451. Emergency or after-hours contact information If you are a University Hospitals patient, and you need to contact study staff outside normal business hours, you may contact 216-844-3951 and you will be transferred to the answering service, which can put you in contact with Paoli Caimi, MD or the oncologist (cancer doctor) on call.  
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receive a rituximab infusion.  These infusions may be given over 4 hours if you tolerated the first rituximab infusion without a reaction.  
You will have Revlimid ®, also known as lenalidomide, pills.  You will take one of these each day starting on day 1 for 21 days.  You will then have 7 days without taking any medication. In the first cycle, on day 22 you will also have blood tests and, if indicated, a pregnancy test.  
This will complete the first 28 day cycle.  
For the remaining treatment cycles (2-12), you will only need to come on the first day of the cycle. On that day you will again have a history and physical examination and some additional blood tests, and a pregnancy test if appropriate.  
You will then receive a rituximab infusion over 2-4 hours, except rituximab will not be given on cycles 7, 9 and 11.  
You will be given ixazomib pills, to take one on that day, and another ixazomib pill 1 week and again 2 weeks later. You will have Revlimid ® pills.  You will take one of these each day starting on day 1 for 21 days.  You will then have 7 days without taking any medication.  
Treatment is complete after the 12 th cycle.  
You will have a CT scan after the third and sixth cycles to see how you're lymphoma is responding to the treatment About 2-3 months after the 12 th cycle, you will be evaluated for how your disease responded to the treatment and how you tolerated the treatment. You will have a doctor visit for a history and physical examination. Blood tests will be drawn. You will have a PET scan. Bone marrow aspiration and biopsy may need to be repeated. This will be discussed at the time by your doctor.  
After that, you will be followed by your doctor in the standard way you would be after any treatment for your lymphoma.
Clinical trial: NCT02898259
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary. Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed.  
In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.