Spots Global Cancer Trial Database for A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT02545283
Conditions
Study Description
Brief Summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwell Health, Great Neck, New York, United States
New York Medical College, Hawthorne, New York, United States
Ichan School of Medicine at Mount Sinai, New York, New York, United States
Abramson Cancer Center; Univ of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Baylor University Medical Center, Dallas, Texas, United States
M.D. Anderson Cancer Center; Department of Hematology, Houston, Texas, United States
Canberra Hospital; Haematology Department, Canberra, Australian Capital Territory, Australia
Concord Repatriation General Hospital; Haematology, Sydney, New South Wales, Australia
Royal Adelaide Hospital; Haematology Clinical Trials, Adelaide, South Australia, Australia
Geelong Hospital; Andrew Love Cancer Centre, Geelong, Victoria, Australia
Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation, Melbourne, Victoria, Australia
Lkh-Univ. Klinikum Graz; Klin. Abt. Fßr Hämatologie, Graz, , Austria
CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul, , Belgium
CHU Sart-Tilman, Liège, , Belgium
AZ Delta (Campus Rumbeke), Roeselare, , Belgium
Juravinski Cancer Clinic; Clinical Trials Department, Hamilton, Ontario, Canada
Helsinki University Central Hospital; Hematology, Helsinki, , Finland
Tampere University Hospital; Hematology, Tampere, , Finland
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang, Angers Cedex 9, , France
Hopital Claude Huriez; Hematologie, Lille, , France
Institut J Paoli I Calmettes; Onco Hematologie 2, Marseille, , France
Hopital Hotel Dieu Et Hme;Hopital De Jour, Nantes, , France
Hopital Saint Louis; Oncologie Medicale, Paris, , France
HOPITAL SAINT ANTOINE;Hematologie Clinique, Paris, , France
Hopital De Haut Leveque; Hematologie Clinique, Pessac, , France
Centre Hospitalier Lyon Sud; Hematolgie, Pierre Benite, , France
IUCT Oncopole; Hematologie, Toulouse, , France
Hopitaux De Brabois; Hematologie Medecine Interne, Vandoeuvre Les Nancy, , France
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm., Aachen, , Germany
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie, Bonn, , Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik fßr Hämatologie und Onkologie, Braunschweig, , Germany
Klinikum Chemnitz gGmbH Krankenhaus KĂźchwald Klinik f.Innere Medizin III, Chemnitz, , Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I, Dresden, , Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hannover, , Germany
Klinik der Uni zu KĂśln; I. Med. Klinik, KĂśln, , Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik, Mainz, , Germany
Universitätsklinikum Marburg Zentrum f. Innere Medizin, Marburg, , Germany
Shaare Zedek Medical Center; Hematology Dept., Jerusalem, , Israel
Hadassah Ein Karem Hospital; Haematology, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus;Hematology-Oncology, Petach Tikva, , Israel
Ichilov Sourasky Medical Center; Heamatology, Tel Aviv, , Israel
Ospedale Cardarelli; Divisione Di Ematologia, Napoli, Campania, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli, Bologna, Emilia-Romagna, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia, Meldola, Emilia-Romagna, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica, Udine, Friuli-Venezia Giulia, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia, Roma, Lazio, Italy
IRCCS AOU S.Martino; Clinica Ematologica, Genova, Liguria, Italy
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
Ospedale San Raffaele, IRCCS, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone, Orbassano (TO), Piemonte, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia, Torino, Piemonte, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia, Firenze, Toscana, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia, Pisa, Toscana, Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Academisch Medisch Centrum; Hematologie, Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service, Auckland, , New Zealand
Haukeland Universitetssjukehus; Klinisk forskningspost, Bergen, , Norway
Oslo Universitetssykehus HF, Rikshospitalet, Oslo, , Norway
Complejo Hospitalario Arnulfo Arias Madrid; Servicio de HematologĂa, Panama City, , Panama
"Hematological Scientific Center, Moscow, , Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta, Saint-Petersburg, , Russian Federation
FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health, Sankt-Petersburg, , Russian Federation
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia, Barcelona, , Spain
Hospital ClĂnic i Provincial; Servicio de HematologĂa y OncologĂa, Barcelona, , Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitario la Fe; Servicio de Hematologia, Valencia, , Spain
Universitätsspital Basel; Hämatologie, Basel, , Switzerland
Universitätsspital Zßrich Medizin Hämatologie; Klinik fßr Hämatologie, Zßrich, , Switzerland
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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