When will I find out my randomization assignment?
You might not find out until the day you return to start treatment on trial. If the information is available sooner, the research nurse will attempt to contact you.
What happens if I am randomized to Arm A, B, or C?
You will start treatment on trial. The study nurse will give you further instructions on how to take your mediation, how to fill out your pill diary, and who to contact with questions or concerns.
If you are randomized to an arm containing Everolimus, you will be given a prescription for a special steroid mouthwash to prevent mouth sores. Please follow these instructions diligently. If you flying, the prescription can be sent to your local pharmacy, please let your study doctor know.
What happens if I am randomized to Arm D?
You have been assigned to the observation arm and you do not need to return to Penn during the 12 week observation period. A research nurse will contact you approximately every two weeks to do an assessment/checkup over the phone.
In addition, you will get labwork done locally at the beginning of the second and third cycle of observation. At the end of the observation period, you will return to Penn for a bone marrow aspiration, labwork, and to start study treatment. Do not eat or drink anything (except water) for 4 hours prior to your scheduled appointment.
How long is a cycle?
A cycle is 28 days. When you start treatment on the trial you will be given a pill diary with a 28 day calendar template. Fill out each pill diary completely, even if your next visit with your study doctor falls a few days before you have completed the 28 days. When you finish your 28 day cycle and have recorded all the information on your pill diary, you should then start filling out your pill diary for the next cycle.
Can my appointment to see my study doctor and my bone marrow aspiration happen on the same day?
Yes. Please let the study team know as soon as possible if this is important to you so we can ensure that the clinician performing the bone marrow aspiration and your study doctor are available to see you on the same day.
What happens when I am done with 6 cycles of treatment? (applicable to any arm)
Complete the 28 days of your cycle 6 medication and complete your pill diary, regardless of which day your bone marrow appointment falls.
After your end of cycle 6 bone marrow you will return in approximately 3 weeks to see your study doctor for disclosure of DTC results. Results of the bone marrow test will only be disclosed in person.
Do not eat or drink anything (except water) for 4 hours prior to your scheduled appointment since you will have study labs drawn on the day of your results disclosure.
What if the results indicate I am DTC negative?
- You will stop taking the study drugs
- You will have an assessment visit with a research nurse after your results are disclosed to you. This will be your first follow-up visit. You will then enter the follow up phase.
- You will have another bone marrow aspiration in 6 months. Your study doctor will explain why this additional testing is important.
What if the results indicate I am still DTC positive?
- You will start, or continue if you are in arm C or D, taking both EVE and HCQ for another 6 cycles. Please note that if you were initially assigned to Arm A or B, you will need to return to Penn every two weeks during the first two cycles of the combination treatment to ensure that you are tolerating the new drug added to your regimen. At the end of these next 6 cycles, you will have another bone marrow aspiration.
What if I am still DTC positive at the end of the study?
Your study doctor will discuss your options. These may include enrollment in another clinical trial that targets DTCs using a different drug and/or a different target.
How long will I be in the follow up phase and what do I have to do?
You will be in the follow-up phase for 3 years. You will have assessments and labwork done every 6 months.
- At your first 6-month follow up visit, you will come to Penn for an assessment with a research nurse. Do not eat or drink anything (except water) for 4 hours prior to your scheduled visit. If your last bone marrow test was negative for DTCs, you will have a repeat bone marrow aspiration at this visit.
- All subsequent follow up visits can be done locally as long as you continue to see your local oncologist on a regular basis, get routine labwork done, and provide us with these records. A research nurse will contact you every 6 months to do an assessment/checkup over the phone. We are currently re-evaluating the collection requirements for extra tubes of research blood during the follow up phase and are working on arranging a way in which this can be done locally and shipped to Penn. Stay tuned for further updates and contact your study team with questions.