CLEVER Study: What to Consider and Expect

If you are DTC positive, things to consider before enrolling in CLEVER:

If travelling from a distance, consider the cost of travel/accommodations.

• The Perelman Center for Advanced Medicine website has list of hotels in the Philadelphia area; you can also search online to try and find a deal. Some hotels have a Penn Medicine room rate for patients and family; call and ask.
• Corporate Angel Network: a charity that helps cancer patients traveling to receive treatment find flights at no cost; best to request flight 3 weeks in advance.
• Look online for other resources for patients traveling for clinical trials.

Participating in a clinical trial is a commitment.

• The CLEVER trial requires you to come in for 2 days when starting the trial, then every two weeks for the first 2 cycles. After starting cycle 3 you will be coming in every 28 days while on treatment. When you are done with treatment we will follow up with you every 6 months for 3 years. You must be able to make all scheduled visits/bone marrow aspirate appointments. These visits ensure your safety while on the trial drugs. We understand unexpected things come up and we will work with you should anything arise but it is important for you to keep in mind that these visits and your health should be a high priority.

What is billed to my insurance/what do I have to pay for/what does the study cover?

• Some of the bloodwork collected during the study is for routine lab evaluations that are normally done during follow up visits with your oncologist. These are billed to your insurance and you are responsible for any copays.
• While on the trial, your study doctor will be assuming your care here. If you do not have an oncologist at Penn, you will come in for a new patient visit during which one of the study investigators (a medical oncologist) will go over your medical history and do a physical exam. This visit might have a copay for which you are responsible.
• The prescription for Hydroxychloroquine (HCQ) will be billed to your insurance and you are responsible for the copay. 
• For more information, please visit: https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying and reach out to your insurance company.

What to expect during your first CLEVER visit (Day 1 and Day 2)

Day 1 of your initial visit (with study doctor) 

• Do not eat or drink anything (except water) for 4 hours prior to your scheduled appointment time.
• If you are a woman of childbearing potential, be prepared to inform your study doctor of the 2 medically approved forms of birth control that you will be using while on the trial and for 8 weeks after you are done taking study medication. (If this applies to you, the study coordinator would have discussed this with you prior to scheduling your appointment).
• Your appointment will be an hour long. The study doctor will go over your medical history, perform a physical exam, go over the trial and answer any questions you may have, and then obtain informed consent.
• After your appointment, you will have blood drawn for eligibility lab assessments and extra tubes of research blood.
• The study coordinator will let you know what time to come in the following day to meet with the research nurse and start on the next phase of the trial. 

Day 2 of your initial visit (with research nurse)

• The study team will inform you of your randomization assignment (if this information is available sooner, the research nurse will attempt to contact you prior to your visit)
•  The research nurse will provide specific instructions based on your assigned study arm.
• The research nurse will help you with scheduling future appointments for the trial.