Spots Global Cancer Trial Database for Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome (SELECT MDS-1)
Study ID: NCT04797780
Conditions
Study Description
Brief Summary: This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.
Detailed Description: A subset of participants have MDS characterized by an overexpression of the RARA gene. A blood test will be used to identify participants with RARA-positive MDS. Assessment of the RARA biomarker for study eligibility will be done by collection of blood samples from potential study participants at the pre-screening visit and testing at a central laboratory. Participants who meet eligibility requirements will be randomized 2:1 to receive either Tamibarotene plus azacitidine or placebo plus azacitidine.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Tucson, Arizona, United States
UC Irvine, Irvine, California, United States
University of Southern California, Los Angeles, California, United States
University of California, Los Angelas, Los Angeles, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Cancer specialists of North Florida, Jacksonville, Florida, United States
Comprehensive Hematology and Oncology, Saint Petersburg, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Orchard Healthcare Research Inc., Skokie, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center), Billings, Montana, United States
Morristown Medical Center- Atlantic Hematology Oncology, Morristown, New Jersey, United States
Montefiore Medical Center & Albert Einstein College of Medicine, Bronx, New York, United States
Northwell Health, Lake Success, New York, United States
Novant Health Inc, Charlotte, North Carolina, United States
Novant Health Cancer Institute - Forsyth, Winston-Salem, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
TriStar - Sarah Cannon BMT, Nashville, Tennessee, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Swedish Cancer Institute, Seattle, Washington, United States
Medical University of Graz, Graz, , Austria
Salzburg Cancer Research Institute (SCRI), Salzburg, , Austria
Klinik Hietzing, Vienna, , Austria
ZNA Middelheim, Antwerp, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Ghent University Hospital, Gent, , Belgium
Hospital De Jolimont, La Louvière, , Belgium
CHU de Liège, Liège, , Belgium
AZ Delta, Roeselare, , Belgium
CHU-UCL Namur, Yvoir, , Belgium
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Center, London, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network, Toronto, Ontario, Canada
McGill University Health Centre (MUHC), Montréal, Quebec, Canada
Tom Baker Cancer Centre, Calgary, , Canada
London Health Sciences Centre, London, , Canada
Fakultni nemocnice Olomouc (University Hospital Olomouc), Olomouc, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
Nemocnice Pelhrimov, Pelhřimov, , Czechia
General University Hospital Prague, Prague, , Czechia
CHU Amiens-Picardie, Amiens, , France
CHU d'Angers, Angers, , France
Centre Hospitalier de la Côte Basque Hématologie Clinique, Bayonne, , France
Hôpital Avicenne, Bobigny, , France
CHRU de BREST - Hôpital Morvan, Brest, , France
CHU Clermont Ferrand / CHU Estaing, Clermont-Ferrand, , France
CHU Grenoble Alpes Hôpital Nord Michallon, La Tronche, , France
Hopital Mignot, Le Chesnay, , France
CHU de Limoges, Limoges, , France
Centre Léon Bérard, Lyon, , France
CHU la Conception, Marseille, , France
CHU Nantes - Hotel Dieu, Nantes, , France
CHU de Nice - Hopital L'Archet, Nice, , France
Hôpital Saint Louis, Paris, , France
Centre Hospitalier de Perpignan, Perpignan, , France
CHU Bordeaux, Pessac, , France
CHU Lyon Sud, Pierre-Bénite, , France
CHU Poiters, Poitiers, , France
CHU Saint Etienne, Saint-Priest-en-Jarez, , France
ICANS Strasbourg, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Universitätsklinikum Augsburg, Augsburg, , Germany
Helios Klinikum Berlin Buch GmbH, Berlin, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
Universitätsklinikum Halle (Saale), Halle, , Germany
Universitätsklinikum Marburg, Marburg, , Germany
Universitätsklinikum Münster, Münster, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Debrecen University Medical and Health Science Centre, Debrecen, , Hungary
Markhot Ferenc Oktatókórház és Rendelőintézet, Belgyógyászati- és Infektológiai Centrum, Eger, , Hungary
Petz Aladar County Teaching Hospital, Győr, , Hungary
Josa Andras Teaching Hospital, Nyíregyháza, , Hungary
Barzilai Medical Center of Ashkelon, Ashkelon, , Israel
Bnai Zion Medical center, Haifa, , Israel
Carmel Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
ASST Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, , Italy
AOU Careggi, Firenze, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona, Meldola, , Italy
A.O.U. Maggiore della Carità, Novara, , Italy
Ospedali Marche Nord Centro Ematologia e Trapianti, Pesaro, , Italy
Ospedale S.Maria delle Croci, Ravenna, , Italy
Ospedale Infermi di Rimini, Rimini, , Italy
Ospedale S. Eugenio - ASL Roma 2, Roma, , Italy
Fondazione Policlinico Tor Vergata, Rome, , Italy
AOUI di Verona, Verona, , Italy
University Clinic Gdansk, Gdańsk, , Poland
Pomeranian Hospital Gdynia, Gdynia, , Poland
Wojewodzki Szpital Specjalistyczny w Legnicy, Legnica, , Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warszawa, , Poland
University Clinic Warsaw, Warszawa, , Poland
Alfred Sokołowski Hospital Wałbrzych, Wałbrzych, , Poland
Institut Catala d'Oncologia - Hospital Duran i Reynals Location, Badalona, , Spain
Hospital del Mar, Barcelona, , Spain
H. Santa Creu i Sant Pau, Barcelona, , Spain
Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital del Mar Secretaria d'Hematologia Clínica, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
H. Universitario La Paz, Madrid, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital General Universitario J.M. Morales Meseguer, Murcia, , Spain
Hospital Universitario Central de Asturia, Oviedo, , Spain
Hospital Son Llatzer, Palma De Mallorca, , Spain
Clinica Universidad Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Donostia, San Sebastián, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen Del Rocio, Seville, , Spain
Hospital Universitario y Politécnico La Fe, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Castle Hill Hospital, Cottingham, Cottingham, , United Kingdom
Ninewells Hospital, Dundee, , United Kingdom
Western General Hospital in NHS Lothian Edinburgh Scotland, Edinburgh, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
The Royal Marsden Foundation Trust, London, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Sandwell and West Birmingham Hospital NHS Trust, West Bromwich, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Syros Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
