Division of Immunotherapy

Stem Cell Transplant Program

Candidate/Patient Handbook


Table of Contents

Chapter 1: Stem Cell Transplant ProgramPages 2-5

Chapter 2: Stem Cell Transplant ProcessPages 6-13

Chapter 3: The Inpatient Stay Pages 14-20

Chapter 4: Reinfusion of Stem Cells Pages 21-22

Chapter 5: Engraftment and Complications Pages 23-27

Chapter 6: Discharge Guidelines Pages 28-44

Appendix 1: Nurtitional Guidelines: Pages 45-47

Appendix 2: Glossary Pages 48- 49

Appendix 3: Frequently Asked Questions Pages 50-51

Appendix 4: Study Road MapPage 52

CHAPTER 1: STEM CELL TRANSPLANT PROGRAM

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The Division of Immunotherapy at Northwestern University has an active program offering promising new therapies using autologous and allogeneic hematopoietic stem cell transplantationin treating autoimmune and non-malignant diseases.

Results have led to randomized trials for several of our protocols. Currently the studies for scleroderma, multiple sclerosis, and Type 1 diabetes are randomized trials. Patients under these studies will be randomly selected to either be treated under the “transplant arm” or “treatment arm”. These studies are designed to compare treatment with standard therapies versus high dose immunosuppression followed by stem cell transplant.

Division of Immunotherapy

750 N. Lakeshore Drive,Suite 649

Chicago, IL 60611

(312) 908-0059

(312)908-0064 Fax

Northwestern Memorial Hospital is a state-of-the-art facility located in the heart of downtown Chicago.

Northwestern Memorial Hospital

251 East Huron Street

Chicago, IL 60611

(312) 926-2000

IMPORTANT PHONE NUMBERS

Clinic:

Call (312) 908-0059 anytime Monday – Friday 9:00 AM – 4:00 PM for an appointment.

Emergency: Call 911

Non-Emergency:

To reach a MD after hours (312) 649-3144 and ask to speak to the doctor on call for the Division of Immunotherapy.

Division of Immunotherapy Office:

(312) 908-0059 (Leave a message on the voice mail. If it is the weekend, someone will return your call on Monday.)

DIVISION OF IMMUNOTHERAPY STAFF

Attending Physicians:

  • Dr. Richard Burt, Chief
  • Dr. Robert Craig

Fellow Physicians:

  • Dr. Sandeep Jain

Nurses:

  • Amy Morgan RN, APN
  • Paula Gozdziak RN, BSN
  • Kristin Boyce RN, BA
  • Kate Quigely, RN, BSN, MBA
  • Kim Yaung, RN, BSN

Secretaries:

  • Kim Bracy
  • Arlene Leitner

FINANCIAL SUPPORT SERVICES

While under the care of the hematopoietic stem cell transplant team, we will make every effort to provide support services to you and your family. This will include financial counseling.

Financial counselors:

Hematopoietic stem cell transplantation is a very costly procedure. The Division of Immunotherapy has three dedicated financial counselors to assist you with the insurance process. You will be asked to fill out an intake form, which will request your insurance information. The financial counselors will provide your insurance company with any medical information required in order to obtain approval and payment for your transplant.

If you are not insured, or are underinsured, there are multiple options available to assist you in funding your procedure as well as the required lodging costs if you are located outside the Chicagoland area:

NTAF: The National Transplant Assistance Fund:

The NTAF is a nonprofit organization that provides fundraising guidance to patients. Specifically, they work with transplant and catastrophic injury patients and their families to afford critical but uninsured medically related expenses through fundraising guidance and patient support.

They can be reached at 1-800-642-8399 or via the web at

HAFH: Home Away From Home:

HAFH is supported through the NTAF. This program helps to defer the costs of an overnight hotel stay when patients are traveling from outside the Chicagoland area for Stem Cell Transplant evaluation. Consideration for this program is based on financial need.

“Patient First” room:

Northwestern Memorial and the Division of Immunotherapy offers free housing to those in need. The Worchester House is on-campus housing that is owned by the hospital and is within walking distance to the medical campus. Each room consists of 2 twin beds, 1 bathroom and a kitchen. The room is available on a first come, first serve basis. Due to its popularity, the waiting list for the free lodging can be several months long. Once a patient’s name has come up and the room has been offered, patients have 24 hours to claim the room. Specifically, the room must be occupied within 24 hours or the room will be offered to the next patient on the wait list. The room is available through discharge, however checking out throughout the hospital stay is prohibited. The room must be occupied through discharge. For more information please call the office at 312.908-0059.

Parking:

As much as we try to control costs, parking is expensive here in downtown Chicago. We cannot offer free parking to patients. We suggest leaving your car at home and traveling to Chicago via O’Hare International Airport or Midway Airport. Cabs are plentiful and are the best means by which to travel from the airport to the medical campus.

Website:

More information on our program can be found at

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Chapter 2: Stem Cell Transplant Process

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TYPES OF HEMATOPOIETIC STEM CELL TRANSPLANTATION

There are three types of hematopoietic stem cell transplants:

autologous, allogeneic and syngeneic.

An autologous hematopoietic stem cell transplant uses your own stem cells that are collected prior to chemotherapy, while an allogeneichematopoietic stem cell transplant uses cells collected from a closely or completely matched individual. Syngeneic hematopoietic stem cell transplant uses cells from an identical twin. In each of these three types of transplants, the stem cells can be collected from the bone marrow or from the peripheral blood.

You and the stem cell transplant team will decide which type of transplant is your best treatment option.

THE TRANSPLANT PROCESS

There are a common series of events that all patientsundergoing a transplant will perform. These steps include:

  • Initial Physician Visit
  • Pre-transplant Testing
  • Central Line Placement
  • Stem Cell Mobilization
  • Stem Cell Harvest
  • Conditioning
  • Stem Cell Reinfusion
  • Follow-up Physician Visits

Once you are accepted into the transplant program, please do not take any new medicines, especially ones that affect bone marrow or platelet function (aspirin type drugs), unless you get permission from the transplant team. This is especially important before placement of the central line and until recovery of your blood counts following completion of the transplant.

Initial Physician Visit:

An initial physician visit is necessary to determine if you are a candidate for one of our studies. Your past medical records, including radiologic studies (MRI, CT scans, x-rays) should accompany you or be sent in advance of your scheduled appointment. During this initial visit, you will undergo a history and physical examination. The transplant process, including potential complications,will be explained to you by the treatment team. You will be given an opportunity to ask questions. In addition, if it is felt that you may be a candidate for the transplant, you will be given the protocol consent form to take home and read. If desired, you will be given an opportunity to talk to other individuals who have undergone a transplant for your disease. You will need to be in Chicago one to two days for this initial evaluation.

If you qualify for a study, you will be given a copy of the consent form and

our financial team will work to obtain insurance approval. Once approval is obtained, you will be notified to return to Chicago for up to 3 months for the study. Please note that it is medically advised that a caregiver be present with you during your stay in Chicago.

Pre-Transplant Testing:

When you return to Chicago, a series of tests will be performed to assess the status of your disease and to ensure eligibility for the study. These tests are described in detail in your consent form. Prior to starting, you will need to sign the protocol consent form. You will be given another opportunity to ask questions of the treatment team before signing the consent form. Once you have completed the testing, the physician will review the results and decide if it is safe to proceed to randomization or on to chemotherapy mobilization.

Randomization:

If you are enrolled on a randomized trial, your study treatment will be decided by chance in a manner similar to flipping a coin. If you are randomized to the control arm, you will return in 6-9 months to reassess the status of your disease.

Central Line Placement:

PICC line:

During the course of transplant, you will need to have a PICC line placed into a large vein in your upper arm. The PICC line usually has two or three “lumens” or entry points exiting out of your upper arm.

The purpose of these central lines will be to help reduce the discomfort of the multiple blood draws that are required throughout the transplant process. In addition, chemotherapy, medications, blood products and the stem cells can be administered through the central line.

Should you go home for a period of time with the central catheter you will be taught how to care for the catheter. You will be required to flush the catheter daily and change the central catheter dressing at least once a week. A home health care nurse will assist you with these procedures until you, or a family member, are able to perform them independently.

Vas Catheter:

When undergoing an autologous hematopoietic stem cell transplant, you will also need to have a second central catheter placed for the collection of your peripheral blood stem cells (this catheter is commonlycalled a VAS CATH). (Note: Donors for allogeneic or syngeneic hematopoietic stem cell transplants may also need to have a VASCATH placed prior to the harvest.) This line is placed the day before or the morning of the first day of your stem cell harvest, and will be removed when the harvest is completed. This

catheter has two large bore lumens, which will allow us to collect your stem cells, draw blood, and administer medications if needed. The catheter is placed into a large vein in your neck that leads to your heart. You will be given a local anesthetic before the procedure. You will not be required to care for this catheter. Flushing and dressing changes will be done in the blood center during your stem cell harvest. This catheter can feel uncomfortable, but will only be in place temporarily.

Stem Cell Mobilization:

After your pre-testing is completed and you are cleared for transplant, stem cells will need to be collected from you (autologous transplant) or your donor (allogeneic or syngeneic transplant).

Allogeneic/Syngeneic Stem CellMobilization: If you are having an allogeneic or syngeneic hematopoietic stem cell transplant, stem cells will be “mobilized” from your donor’s bone marrow to the peripheral blood where they can be collected using a growth factor called Neupogen® (GCSF). Approximately 3-4 days after starting the Neupogen® (which is given daily by subcutaneous injection), your donor’s stem cells will be collected (harvested). The stem cell harvest for your donor will take 1-5 days depending on how successful the harvest is each day.

Autologous Stem Cell Mobilization:

Mobilization is a ten day process that consists of mobilizing the stem cells from the bone marrow into the blood stream. If you are having an autologous hematopoietic stem cell transplant, you will be admitted overnight to the hospital to receive mobilizationchemotherapy.

The admission will consist of chemotherapy (Cytoxan) and intraveneous hydration to flush the chemotherapy out of your body.

Acute side effects from this chemotherapy may include fatigue, anorexia, nausea, vomiting, and diarrhea. There will be anti-nausea and anti-diarrhea medications available during your hospitalization, as well as when you are discharged. Side effects from the chemotherapy can occur up to several weeks following its administration.

After 24 hours of hydration, you will be discharged. It is important to do the following after you are discharged from the hospital:

  1. Continue to drink fluids to flush the chemotherapy out of your system.
  2. Take your temperature 2x day. Your immune system will drop approximately 7 days after the chemotherapy.
  3. Prevent nausea. You will be given a prescription by the physician to prevent nausea. It is much easier to prevent than to reverse. At first sign of nausea, you should take one of the anti nausea medications.
  4. Neupogen injections- start 5 days after chemotherapy. This is to stimulate your stem cells to move out of the bone marrow into the bloodstream. You or your caregiver will need to give to you every morning at 7 a.m. Take out of the refrigerator one hour prior to administration to increase comfort.
  1. Prevent Infections- On the same day you start Neupogen, you will start taking a prescribed antibiotic and antifungal therapy to prevent infection. You will continue to take until stem cell collection is complete. It is important that you avoid large crowds and individuals who are ill.
  1. Lab Draws- will be needed and instructed by your discharging physician. Your white blood cells will drop 7 days after chemotherapy and you will be neutropenic for approximately 3 days. It is during this time that you will be susceptible to infections.

You will have your blood counts monitored several times during the following week. You will need to come to the hospital to have your blood drawn, or you may be eligible for home health care nursing. We will be expecting your blood counts to be stable until approximately 7 days following your mobilization chemotherapy. At that time, your white blood cells will drop, and you may become neutropenic for approximately 3 days. It is during this time that you will be susceptible to infection anda neutropenic diet should be followed.(See Appendix1 for guidelines)

What to expect from mobilization:

Alopecia:

In addition to fatigue, nausea, and diarrhea, patients will experience chemotherapy induced hair loss.

You will loose your hair approximately 14 days after your mobilization chemotherapy. You should not expect your hair to begin growing back until several months after the transplant.

A company such as located on the internet at: at (773) 787-7799 charlesifergan.com has resources for you to consider during the period of time you are without your natural hair. This includes care products, hair products including eyebrows, eyelashes, wigs, hats and accessories for men and women.

Fashionable scarves are also popular. The Beau Beau is an attractive scarf made for women and girls with medical hair loss. You can learn more and order at

“John Crager Alternatives” is a Chicago-based resource available to all patients interested in learning about hair loss alternatives. John can help patients obtain wigs and can provide tips about styling throughout the hair’s transitional process. John has two salons where he can meet privately to discuss patient’s options. Additionally, John often frequents Northwestern Memorial Hospital to meet with patients. He can be reached at 312.565-1900 or at

Neupogen Side Effects:

The purpose of the Neupogen® is to stimulate your stem cells to grow and find their way from the bone marrow to your peripheral blood for a successful harvest. Side effects of the Neupogen® may include:

  • Flu-like symptoms, including

fever, muscle pain/aches, nausea and headache.

  • Bone pain, which may be severe.
  • Generalized rash.

You may take Tylenol for any of the above symptoms, unless otherwise directed by your physician.

To prevent infection following mobilization chemotherapy, it is advised that you do not come in contact with individuals who are sick. In addition, you should avoid large crowds.

You may feel fatigued. In addition, you may run a temperature. If you develop a fever (100.5F or greater), are unable to eat or drink enough fluids, experience bleeding, have chills, or just do not feel good, you should contact the transplant team immediately as you may need to be admitted to the hospital.

IT IS VERY IMPORTANT THAT YOU NOTIFY YOUR NURSE OR PHYSICIAN IMMEDIATELY OF THE FOLLOWING:

  • FEVER OR CHILLS
  • ANY SIGN OF INFECTION
  • BLEEDING
  • AN INABILITY TO EAT, DRINK, OR TAKE YOUR MEDICATIONS
  • ANY UNCONTROLLED SIDE EFFECT .

Stem Cell Harvest/Apheresis:

Allogeneic/SyngeneicStem CellTransplant: If you are undergoing an allogeneic or syngeneic hematopoietic stem cell transplant, the stem cells will be harvested from your donor on an outpatient basis. The stem cell harvest will begin approximately 4 days after your donor starts taking Neupogen® shots (the timing of the start of the harvest may vary between different research protocols). The stem cell harvest, which will take approximately 4-5 hours each day, will continue on a daily basis until enough stem cells have been collected (approximately 1-5 days). In many instances, your donor will need to have a VASCATH placed on the morning of the first stem cell harvest. This catheter will be removed when enough stem cells have been collected. It will be important for your donor to continue taking the Neupogen® shots until the stem cell harvest is completed.

Autologous Stem Cell Transplant: If you are undergoing an autologous hematopoietic stem cell transplant, your stem cell harvest will be performed as an outpatient, unless you have been hospitalized after your mobilization chemotherapy due to illness or complications. The stem cell harvest will start when your white blood cell count and platelets have recovered, which is approximately 10 days following administration of your mobilization chemotherapy. It is important to remember that your Neupogen®should be given prior to coming to your harvest each day, ideally two hours prior to your scheduled visit.

You will be advised where and what time you will need to have your blood drawn that morning.