Spots Global Cancer Trial Database for Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
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Trial Identification
Brief Title: Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia
Study ID: NCT05020665
Study Description
Brief Summary: The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).
Detailed Description: This is a multi-center, international, double-blind, placebo-controlled study in previously untreated participants with acute myeloid leukemia (AML) harboring nucleophosmin-1 (NPM1) mutations. Upon fulfillment of all eligibility criteria, participants were randomized 1:1 to receive intensive chemotherapy in combination with either the spleen tyrosine kinase (SYK) inhibitor entospletinib (ENTO), or placebo. The study consisted of Screening, Induction, Consolidation, End-of-Treatment, and Long-term Follow-up phases.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
UCLA - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Indiana Blood & Marrow Transplantation, Indianapolis, Indiana, United States
University of Michigan Medical School, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Mount Sinai Health System, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Bon Secours St. Francis Cancer Center, Greenville, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba, , Brazil
Hospital Universitário Walter Cantídio, Fortaleza, , Brazil
Hospital Amaral Carvalho, Jaú, , Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre, Porto Alegre, , Brazil
Instituto Nacional de Câncer - Brazil, Rio De Janeiro, , Brazil
Hospital de Base - São José do Rio Preto, Rio Preto, , Brazil
A Beneficência Portuguesa de São Paulo - Unidade Mirante, São Paulo, , Brazil
Instituto Brasileiro de Controle do Câncer - São Camilo Oncologia - Unidade Mooca, São Paulo, , Brazil
Juravinski Hospital, Hamilton, , Canada
Saskatchewan Cancer Agency, Saskatoon, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Fakultni Nemocnice Brno, Brno, , Czechia
Fakultní Nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní Nemocnice Královské Vinohrady, Praha, , Czechia
Hôpital Côte De Nacre, Caen, Calvados, France
Centre Hosptitalier Universitaire d'Angers, Angers, , France
Hôpital Claude Huriez, Lille, , France
Hôpital l'Archet, Nice, , France
Hôpital Saint-Antoine, Paris, , France
Hôpital Saint-Louis, Paris, , France
Hôpital Necker-Enfants Malades, Paris, , France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, , France
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel, Rouen, , France
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Helios St. Johannes Klinik, Duisburg, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
Medizinische Hochschule Hannover, Hanover, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Universitätsklinikum Münster, Münster, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Jósa András Oktatókórház, Nyíregyháza, , Hungary
Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Samson Assuta Ashdod University Hospital, Ashdod, , Israel
Shamir Medical Center (Assaf Harofeh), Be'er Ya'aqov, , Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assuta Hospital - Ramat HaHayal, Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania, Sicily, Italy
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari, Bari, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara, , Italy
Ospedale Santa Maria delle Croci di Ravenna, Ravenna, , Italy
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Seoul National University Hospital, Incheon, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdańsk, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr im. Prof. Tadeusza Sokołowskiego, Szczecin, , Poland
Uniwersyteckie Centrum Kliniczne WUM - Centralny Szpital Kliniczny, Warsaw, , Poland
Instytut Hematologii I Transfuzjologii, Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wrocław, , Poland
Hospital Germans Trias i Pujol, Badalona, Catalonia, Spain
Institut D'Investigacions Biomédiques August Pi I Sunyer, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Son Llàtzer, Palma De Mallorca, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Contact Details
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