Clinical Research Program Information for Patients. Transplant Creations

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1 Clinical Research Program Information for Patients Transplant Creations 1

2 Program Focus Combination chemotherapy and transplantation of stem cells from an autologous donor (patient s own stem cells) and/or allogeneic donor (family or unrelated) as part of a therapeutic strategy: 1) Early during the disease course/or during the first treatment for bone marrow cell cancer (leukemia), lymph node cancer (lymphoma), plasma cell cancer (multiple myeloma), neuroblastoma or early advanced (locally advanced and metastatic) breast cancer, and 2) At relapse after prior autologous transplantation on indication Non-myeloablative preparative chemotherapy before infusion of stem cells (better tolerated than ablative (high-dose) chemotherapy). 2

3 Treatment Strategy The treatment is a combination of: Intensified and non-myeloablative chemotherapy To minimize cancer cell or disease burden and aim for complete remission (disappearance) of your disease Blood or bone marrow transplantation To restore your bone marrow function after preparative chemotherapy by infusion of your own cells (autologous and allogeneic) To administer powerful immune therapy to eradicate residual cancer cells (allogeneic) 3

4 Treatment Perspectives The combination treatment offers a most powerful therapy at reasonable risk. This type of combination treatment offers in general the highest probability of cure of your disease when administered early during the disease course. Delay in start of this therapy or other treatment first may reduce the likelihood of cure. 4

5 Responsibilities You as patient to inquire about the treatment at first diagnosis and at relapse after prior autologous transplant. Your doctor to discuss your eligibility (suitability) for treatment and to refer you timely to treatment centers that are involved in our studies and can administer this type of treatment. Transplant Creations to inform whether we have studies in which you can participate based on your disease. 5

6 Participation in a Study Hospitals that participate in our studies have expertise in transplantation. Study center s Institutional Review Boards or Ethics Committee s must approve the study protocol. Before you can participate your doctor should give you written information (called Informed Consent) about the study. We will provide the doctor with such information. You should confirm participation in a study in writing. 3 rd edition,

7 Evaluation during a Study During a study of our program you receive treatment according to a written protocol. Medical examination and tests are defined in the protocol. Although there may be a few additional evaluations, the type and frequency of examinations and tests do not exceed those you should have received outside study context. Medical care during a study is in general equivalent to, or better than care outside study context. 7

8 Follow-up after Treatment After you have completed the treatment defined in the study protocol, you will be followed regularly as is usual in patient care after chemotherapy and transplantation. 8

9 Studies We will post our studies and the eligibility criteria for enrollment into the study on the Patient Information website. You can then inform your doctor about the study. You can contact us for study centers that participate in our studies. 9

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