CURRENT RESEARCH STUDIES
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1 CURRENT RESEARCH STUDIES SCAGO SICKLE CELL RESEARCH DAY MAY 12, 2018 REBECCA LEROUX RN, BSCN, CCRP RED BLOOD CELL DISORDERS PROGRAM, UNIVERSITY HEALTH NETWORK MANUELA MERELLES-PULCINI RN, BSCN, MSN, CCRP HEMOGLOBINOPATHY PROGRAM, THE HOSPITAL FOR SICK CHILDREN
2 OBJECTIVES Review complications related to Sickle Cell Disease, and opportunities for research Identify current opportunities for both observational and interventional studies at both the Hospital for Sick Children and Toronto General Hospital Explore the possibilities for future research in Sickle Cell Disease
3 SICKLE CELL IT S MORE THAN PAIN Retinopathy Asthma Acute Chest Syndrome Pulmonary Hypertension Cholelithiasis Hepatopathy Nephropathy Avascular Necrosis Osteoporosis Pregnancy Complications Aplastic crisis Stroke Silent infarct Vasculopathy Moyamoya Infection Asplenism Splenic sequestration crisis Dactylitis Priapism Leg ulcers
4 APOPHARMA STUDY Patients with sickle cell disease who require regular blood transfusions over time will develop iron overload (a build up of iron in blood and organs) that over time can cause serious medical problems This study is comparing the iron chelator Ferriprox to Deferoxamine The study is enrolling children greater than 2 years old from North America, Europe & Egypt). The research treatment in this study is Ferriprox a liquid or tablets taken by mouth three times a day or Deferoxamine is taken subcutaneously (through a needle inserted under the skin) with the use of an infusion pump Patients enrolled for a period 1 year
5 APOPHARMA EXTESNION STUDY Participants who took part in the initial study will be offered the opportunity to take part in this extension study Patients who had been treated with deferiprone during the first study (Group 1) will continue to receive deferiprone for an additional 2 years Patients who had been treated with Deferoxamine (desferal) during the first study (Group 1I) will be switched to deferiprone for 2 years
6 TICAGRELOR STUDY Sickle cell disease can be very painful and it is important to try to find more treatments. This study will test a potential new treatment Ticagrelor is a drug, which may lower how sticky platelets are in blood vessels Sticky platelets might also make sickle cell pain worse. It is possible that by making platelets less sticky it might ease sickle cell pain. The study is enrolling children and teens between 2 to 17 years old from North America, Europe, Middle East and Africa. The research treatment in this study is a liquid taken by mouth twice a day Patients enrolled for a period 2 years
7 RIVIPANSEL STUDY (RESET TRIAL) A potential new treatment for patients admitted to hospital with a sickle cell pain crisis Study is attempting to determine if Rivipansel (study medication) can decrease the severity and length of a painful crisis when given with standard pain medication Participants will be assigned to receive the study medication, or placebo The study is enrolling patients over the age of 6 years old from 70 hospitals in North America. Telen, MJ et al. Blood 2015; 125: Randomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use
8 RIVIPANSEL EXTESNION STUDY (RESET TRIAL) Participants who took part in the initial study will be offered the opportunity to take part in this extension study All patients will be offered the study medication Rivipansel (no placebo!) for every pain crisis they are admitted for up to 2 years
9 CANAKINUMAB ACZ885 STUDY Patients with sickle cell disease have red blood that can become stiff and sticky and get stuck in small vessels when circulating, red cells can also break and spill their contents into the blood causing inflammation, slower blood flow and reduced oxygen delivery to parts of the body. Participants will be assigned to receive the study medication Canakinumab, or placebo. The study is enrolling patients years of age from 10 hospitals in Canada, Germany, South Africa, Turkey, The United Kingdom, and the United States of America. Patients enrolled for a period 1.5 years
10 SICKLE CELL SC DISEASE STUDY Patients with Hemoglobin SC, Sickle Cell Disease Involves the collection of 1 blood sample at a clinic visit The study is trying to determine if differences in genetics result in differences in disease severity
11 KINETICS STUDY PATIENTS ON EXCHANGE TRANSFUSION This study is for patients with sickle cell anemia who are on a chronic exchange transfusion program (automated or partial manual) The study is attempting to determine why some people can bring down their sickle hemoglobin below target, while otehrs cannot The study involves obtaining blood samples at and between 2 red blood cell exchanges
12 RUDAS STUDY USING A STANDARDIZED QUESTIONNAIRE TO PREDICT THINKING AND MEMORY ISSUES IN SICKLE CELL DISEASE All adult patients with Sickle Cell Disease may be offered the opportunity to take part Participants will complete a couple of short questionnaires, and undergo brain imaging (MRI) The study is attempting to validate the RUDAS questionnaire as a reliable way to assess patients cognitive function in adults with sickle cell disease
13 VOXELOTOR GBT440 STUDY Shown in previous clinical studies to increase oxygenation of the red blood cell, therefore stabilizing and decreasing sickling Decreased incidence of the vasoocclusive pain crisis
14 VOXELOTOR EXTENSION GBT440 STUDY Participants who enrolled in the initial study will be offered the opportunity to continue receiving the drug after the study ends Those who received placebo will now be offered the study medication This study will continue until the drug is approved by Health Canada
15 ALYX MACHINE STUDY: EXCHANGE TRANSFUSION PILOT STUDY An alternative treatment option to partial manual exchange in Sickle Cell Disease Using the Alyx machine for exchange transfusion to decrease procedure time, limit symptoms related to changes in blood volume, and more effectively hit target Hb S levels
16 BONE MARROW TRANSPLANT STUDY This study is for participants with severe forms of Sickle Cell Disease Patients will enter the study, then search for a matched donor to donate their stem cells If a donor is found, patients will move forward to receive the bone marrow transplant. If no donor is found, patients will go into the observational group of the study
17 THE FUTURE OF RESEARCH IN SICKLE CELL DISEASE: GENETHERAPY!
18 GENE THERAPY STUDY: COLLABORATION WITH CCHMC High-risk, high reward therapy Patients with S-ߺ thalassemia or Hb S-ß+ thalassemia Patients will be identified from Toronto General Hospital, but will be given the opportunity to travel to Cincinnati Children s Hospital Medical Centre, to receive this experimental treatment
19 GENE THERAPY STUDY: COLLABORATION WITH CCHMC SCD patients of TGH Follow-up between TGH and CCHMC Consent conference at TGH Gene transfer procedure at CCHMC Screening at CCHMC Routine SCD care at TGH
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21 QUESTIONS?
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Index. Note: Page numbers of article titles are in boldface type.
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Transcript Details This is a transcript of an educational program accessible on the ReachMD network. Details about the program and additional media formats for the program are accessible by visiting: https://reachmd.com/programs/changing-conversation-sickle-cell-disease/sickle-cell-disease-howshould-you-reassess-management-treatment/10184/
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