The Mayo Clinic CAR-T Cell Therapy Program is one of a few such landmark programs at select medical centers, with experts trained and certified to manage CAR-T cell therapy. Mayo Clinic was one of the centers that treated people as part of the clinical trial that led to FDA approval of CAR-T cell therapy.

CAR-T cell therapy may be a treatment option for:

  • Relapsed, refractory B-cell acute lymphoblastic leukemia
  • Relapsed, refractory B-cell non-Hodgkin's lymphoma
  • Relapsed, refractory mantle cell lymphoma
  • Other types of cancer and medical conditions undergoing clinical studies

If you are eligible for CAR-T cell therapy at Mayo Clinic and scheduled for this treatment, you will undergo a process that takes many weeks.

Appointments. You will have many appointments and tests before and after CAR-T cell therapy. Depending on where you live, you may need to be away from home for periods of time throughout the CAR-T cell therapy process.

Caregivers. At least one other person should come with you to all of your appointments. A caregiver needs to stay with you 24 hours a day when you are not staying in the hospital during chemotherapy, infusion and care after infusion.

Treatment plan. Ongoing care may be needed for months to years after CAR-T cell therapy. During the CAR-T cell therapy process, your health may change in a way that infusing CAR-T cells may no longer be an option.

CAR-T cell therapy is an individualized cell-based technique that involves removing some of your own white blood cells, including T cells. To make CAR-T cells, the collected T cells are genetically treated in the lab to produce special receptors called chimeric antigen receptors, or CARs. These CARs allow the T cells to recognize an antigen (or marker) at the surface of cancer cells and activate T cells' ability to kill these cancer cells. The CAR-T cells are infused back into your body to identify and destroy certain cancers. This immunotherapy is one of the most promising areas of cancer treatment.

Conditions treated

The FDA-approved conditions for CAR-T cell therapy include:

  • B-cell precursor acute lymphoblastic leukemia (ALL), in people up to 25 years of age
  • Diffuse large B-cell lymphoma (DLBCL)
  • Primary mediastinal large B-cell lymphoma
  • Large B-cell lymphoma transformed from follicular lymphoma
  • High grade B-cell lymphoma
  • Aggressive B-cell lymphoma not otherwise specified (NOS)
  • Mantle cell lymphoma

People who have relapsed or refractory disease may be eligible for CAR-T cell therapy.

Possible side effects

Most people have a reaction to CAR-T cells that requires them to stay in the hospital for days to weeks for monitoring and management. Typically, the reaction happens within hours to days after the infusion. Side effects may include:

  • Low blood counts from the conditioning chemotherapy
  • Cytokine release syndrome (CRS), which causes a fever, fast heart rate, low blood pressure and low blood oxygen
  • Neurologic effects known as neurotoxicity, which can cause confusion, tremors or difficulty with communication

Side effects are generally reversible. Your care team will talk with you about how to monitor for reactions. The long-term toxicity of CAR-T cell therapy is still being studied. Talk with your doctor about the potential risks of treatment.

Evaluation

To be considered for the Mayo Clinic CAR-T Cell Therapy Program, most patients must have already received standard of care chemotherapies.

The CAR-T cell therapy process starts with an evaluation from a Mayo Clinic doctor who specializes in the type of cancer or medical condition you have. This appointment is often called the initial evaluation. Your specialist will review your medical records and talk with you about your disease, diagnosis, past treatments, and treatment options available at Mayo Clinic specifically tailored to your condition and needs. He or she may have you undergo additional tests.

Bring with you all of your medical information, including:

  • Medical records
  • Tissue and slides from your most recent biopsy
  • Images from your most recent radiology scans

Having this information with you can help prevent delays or repeat scans or procedures. For this initial evaluation, plan on staying near Mayo Clinic for up to five business days in order to complete needed tests.

After completing scheduled tests and appointments, you will talk with a member of your team about available treatment options that meet your unique situation. CAR-T cell therapy may not be an option for everyone. If CAR-T cell therapy is an option for you, your team discusses additional evaluation steps where you will meet with a CAR-T cell specialist and many other specialists who can help assess your health.

To proceed with further evaluation for CAR-T cell therapy eligibility, you and your doctor will develop a plan that includes additional required testing and the timing of the infusion. Whenever possible, evaluations will be completed within one week.

The wait time for a CAR-T cell therapy appointment depends on several factors, including your condition, laboratory capacity and the demand for services. Mayo Clinic is committed to ensuring all people offered an appointment receive timely and excellent care and works to reduce the wait time as much as possible. Most people return home while waiting for an appointment to become available.

Insurance coverage and prior authorization

Most health insurance companies require a prior authorization for CAR-T cell therapy. Mayo Clinic's business office will work with your insurance company to get written approval and identify the plan of coverage. Additional treatment steps cannot begin until Mayo Clinic receives approval from your insurance company.

What to expect during your CAR-T cell therapy

Collection

You will undergo the process of white blood cell collection known as leukapheresis. During collection, you will be connected to a machine that separates your white blood cells from the rest of your blood. The collection process takes about five hours.

This may be done during the same visit as your CAR-T cell consultation, depending on the timing of the completion of insurance authorization and testing. Or you may need to return to the clinic at a later time for this collection.

Processing

Once enough white blood cells are collected, the cells are shipped to a special laboratory for processing where the T cells are genetically modified to activate their ability to kill your cancer. This process can take, on average, a few weeks. Most people return home during this phase.

Your care team will talk with you about how long you can expect processing to take and how to track the progress of your cells. You will need to follow the management plan outlined by your care team and report any new or worsening symptoms to your CAR-T care team using the instructions provided.

Chemotherapy before infusion

When your cells are ready, you will return to Mayo Clinic for treatment. Testing and appointments are needed to make sure you are ready to have the CAR-T cells infused into your body. It is important to understand that, even at this point, testing may show that CAR-T cell therapy is no longer a treatment option.

In preparation for your CAR-T cell infusion, you will undergo chemotherapy. Most people start chemotherapy about five days before CAR-T cell infusion. At this time, day-to-day care likely changes to a hospital-based care team. Your care team monitors your health and progress each day. You may have daily lab tests.

From this point on, plan on being at Mayo Clinic for many weeks, depending on your medical needs. During this time, you will need to stay within 30 minutes of Mayo Clinic and will not be able to drive for many weeks following infusion. Talk with your care team about driving restrictions after CAR-T cell infusion.

Infusion

After chemotherapy, the CAR-T cell infusion can take place. The day the CAR-T cells are put into your body is also called day zero. The infusion of CAR-T cells typically takes 30 to 90 minutes. However, plan for the infusion visit to take up to six hours to allow for care before and after the infusion.

Once your infusion is complete, your CAR-T doctor will tell you if you need to stay in the hospital for monitoring. Caregivers should remain with you 24 hours a day when you are not in the hospital.

Care after infusion

You will be monitored closely for many weeks after the CAR-T cell infusion. Frequent monitoring can help identify potentially life-threating reactions to CAR-T cell therapy early. Monitoring may include physical exams, blood tests and assessing your ability to do simple tasks. You may have one or more physical exams each day at the beginning. You may be asked to do simple, self-monitoring tasks several times a day.

Most people have a reaction to CAR-T cells that requires them to stay in the hospital for days to weeks for monitoring and treatment. Typically, the reaction happens within hours to days after the infusion. Not all people have a reaction.

Returning home

You will meet with your CAR-T cell specialist to understand the effect of the therapy and develop a plan for the future and for returning home. Once your health is stable, your care will transfer back to your local care provider.

In general, you will need to return to Mayo Clinic frequently for appointments during the first year after CAR-T cell therapy, and ongoing care may be needed for months to years after CAR-T cell therapy.

An opportunity to be part of research

If you are eligible to undergo treatment at the Mayo Clinic CAR-T Cell Therapy Program, your doctor may invite you to be part of one of multiple clinical trials testing CAR-T cell therapy in your condition.

Mayo Clinic is also testing this treatment in other types of cancer and medical conditions. Talk with your doctor about whether you may be eligible.

Appointments

Be sure to mention that you are interested in learning if CAR-T cell therapy will be an option for your care. Please call to check if we have CAR-T cell therapy for your cancer type and to request an appointment for a consultation.

  • Rochester: 507-284-8707
  • Arizona: 480-342-4800
  • Florida: 904-956-3309

Costs and insurance

CAR-T cell therapy is a newer type of cancer treatment that may be more expensive than other therapies. Not all insurance policies cover CAR-T cell therapy. The out-of-pocket cost for CAR-T cell therapy will vary depending on the level of coverage your insurance offers for both services at Mayo Clinic and CAR-T cell therapy itself.

When considering your treatment options, work with your health insurance provider to understand what costs are covered by your insurance and which costs you'll be expected to pay. When you are seeking to understand insurance coverage for CAR-T cell therapy at Mayo Clinic, we suggest you call your insurance company and ask the following questions:

  • Does my insurance plan include coverage at the Mayo Clinic location I am seeking treatment at?
  • Does my insurance plan provide coverage for CAR-T cell therapy? If not, is there a review process?

Your treatment can't begin until Mayo Clinic confirms with your insurance company that you're covered and preauthorized for CAR-T cell therapy.

Mayo Clinic has one of the largest and most experienced practices in the United States, with campuses in Arizona, Florida and Minnesota. Staff skilled in dozens of specialties work together to ensure quality care and successful recovery.

Find doctors and medical staff:

What is chimeric antigen receptor (CAR)-T cell therapy?

CAR-T cell therapy is a kind of immunotherapy. It involves harnessing the power of a person's own immune system by engineering T cells to recognize and destroy cancer cells.

Will this work for my type of cancer?

The FDA-approved conditions for CAR-T cell therapy include:

  • B-cell precursor acute lymphoblastic leukemia (ALL), in people up to 25 years of age
  • Diffuse large B-cell lymphoma (DLBCL)
  • Primary mediastinal large B-cell lymphoma
  • Large B-cell lymphoma transformed from follicular lymphoma
  • High grade B-cell lymphoma
  • Aggressive B-cell lymphoma not otherwise specified (NOS)
  • Mantle cell lymphoma

How do I know if I'm eligible for CAR-T cell therapy at Mayo Clinic?

In order to be eligible for CAR-T cell therapy, typically you must have already received standard of care chemotherapies. Mayo Clinic doctors will evaluate you to understand how to best treat your disease and to understand if CAR-T cell therapy may be an option.

What should I do if I think I or a loved one is eligible for treatment?

If you think you or a loved one is eligible for CAR-T cell therapy at one of Mayo Clinic's three locations, please call the phone number below to request an appointment at the location you are interested in seeking care at. Our appointment staff will work to find the specialist who can best address your questions and needs. Be sure to mention that you are interested in CAR-T cell therapy to ensure your request is routed correctly.

  • Minnesota: 507-284-8707
  • Arizona: 480-342-4800
  • Florida: 904-956-3309

Who can my non-Mayo Clinic doctor talk to at Mayo Clinic about CAR-T cell therapy?

Mayo Clinic hematologists are happy to discuss possible referrals with doctors and allied health staff outside of Mayo Clinic. Your doctor needs to mention that you are interested in understanding whether CAR-T cell therapy may be appropriate for you. Patient appointments are scheduled Monday through Friday from 8 a.m. to 5 p.m. local time at each campus. Consultations with Mayo doctors are also available during these hours.

Minnesota: Have your doctor call the Hematology Department directly at 507-284-8707 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 800-533-1564.

Arizona: Have your doctor call the Hematology Department directly at 480-342-4800 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 866-629-6362.

Florida: Have your doctor call the Hematology Department directly at 904-956-3309 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 800-634-1417.

How soon can I expect to get an appointment at Mayo Clinic for CAR-T cell therapy?

Mayo Clinic is typically able to offer you an appointment within one to two weeks with a provider who specializes in the type of cancer or medical condition you have. Once you have been evaluated by the necessary specialists and determined to be eligible for CAR-T cell therapy, Mayo Clinic will work with you to schedule treatment. The appointment time depends on several factors, including your condition, laboratory capacity and the number of people seeking this treatment.

How much does CAR-T cell therapy at Mayo Clinic cost?

CAR-T cell therapy is a newer type of cancer treatment that may be more expensive than other therapies. Not all insurance policies cover CAR-T cell therapy. The out-of-pocket cost for CAR-T cell therapy varies, depending on your insurance coverage for services at Mayo Clinic as well as for CAR-T cell therapy itself.

Will my insurance cover CAR-T cell therapy?

In order to determine if your insurance company will cover CAR-T cell therapy, please call your insurance company and ask the following two questions:

  • Does my insurance plan include coverage at the Mayo Clinic location I am seeking treatment at?
  • Does my insurance plan provide coverage for CAR-T cell therapy? If not, is there a review process?

We will work with you and your health insurance company to determine if CAR-T cell therapy will be covered, if that is the recommended treatment. This includes any appeals process with the insurance company.

Who do I need to bring with me during my CAR-T cell therapy?

During your CAR-T cell therapy, you may not be able to do things you can normally do for yourself well or safely. A caregiver helps you get through this process. The caregiver provides physical and emotional support and, sometimes, acts as an advocate for you.

Some tasks a caregiver might do for you:

  • Oversee your daily needs such as keeping track of medications, nutrition and monitoring for changes in your health
  • Help you to stay organized and manage details
  • Attend all your health care appointments with you
  • Communicate with the CAR-T cell therapy team about your care
  • Grocery shop, prepare meals or do housekeeping tasks
  • Support you in your choices
  • Be there to call for help if needed

The caregiver also needs to be your cheerleader, someone to give you words of encouragement, keep you going, cheer you up, make you laugh and help you get through it all.

How long will I need to be near Mayo Clinic for treatment?

Once you have been identified as a candidate for CAR-T cell therapy, you may need to make several trips to Mayo Clinic to determine your eligibility for the therapy as well as to meet with a doctor to make a plan for your care.

Evaluation: For this initial evaluation, plan on staying near Mayo Clinic for up to five business days in order to complete needed tests.

Collection: Depending on the timing of insurance approval, the collection may occur as soon as the week following the completion of evaluation. The collection process will take a minimum of two days.

Processing: Most people return home during this phase.

Chemotherapy before infusion: From this point on, plan on being at Mayo Clinic for many weeks depending on your medical needs. During this time, you'll need to stay within 30 minutes of Mayo Clinic.

Infusion: The infusion of CAR-T cells typically takes 30 to 90 minutes. However, plan for the infusion visit to take up to six hours to allow for care before and after the infusion.

Care after infusion: You will be monitored closely for many weeks after the CAR-T cell infusion.

What can I expect after CAR-T cell therapy?

Initially, after your CAR-T cell therapy, you will have appointments with the Mayo Clinic team as frequently as every month. As your health improves and there are fewer signs of disease, the appointments will become less frequent. Anticipate at least annual visits to Mayo Clinic.

Because CAR-T cell therapy is a form of gene therapy, the FDA requires a 15-year monitoring.

What is it like at Mayo Clinic? How do I get there? Where do I stay?

We want to help make your travel to Mayo Clinic as easy as possible. We provide information and a variety of services to help.

Minnesota: Mayo Clinic's campus in Rochester, Minnesota, has free Concierge Services to help plan your stay, and fee-based Patient Travel Services.

Why choose Mayo Clinic for CAR-T cell therapy?

At Mayo Clinic, the needs of the patient come first. The CAR-T Cell Therapy Program doctors and other specialists consult with their colleagues about your condition and recommend treatment options based on their experience and evidence-based medicine. Mayo Clinic's experts have treated people in the landmark clinical trial that led to FDA approval of this innovative therapy. This program is one of a very few such programs at select medical centers with experts trained and certified to manage CAR-T cell therapy as clinical practice.

Questions to ask your doctor

  • How is the treatment given and what is the procedure like?
  • Is a hospital stay required before, during or after treatment?
  • How many treatments are needed and how long will they take to be given?
  • What are the risks and side effects of treatment?
  • What is the cost for treatment? Is it covered by insurance?
  • What are the alternatives?
  • What are the chances of remission or cure?

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