Last updated on October 2017

A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)


Brief description of study

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), leukemia-free survival (LFS) 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.

Clinical Study Identifier: NCT02545283

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Canberra Hospital; Haematology Department
Canberra, Australia
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Reference Study ID Number: WO29519 ...

Concord Repatriation General Hospital; Haematology
Sydney, Australia
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Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide, Australia
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Geelong Hospital; Andrew Love Cancer Centre
Geelong, Australia
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Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation
Melbourne, Australia
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Lkh-Univ. Klinikum Graz; Klin. Abt. F r H matologie
Graz, Austria
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Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria
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UZ Leuven Gasthuisberg
Leuven, Belgium
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AZ Delta (Campus Wilgenstraat)
Roeselare, Belgium
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Cancer Care Manitoba
Winnipeg, MB Canada
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Juravinski Cancer Clinic; Clinical Trials Department
Hamilton, ON Canada
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Ottawa General Hospital
Ottawa, ON Canada
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Helsinki University Central Hospital; Hematology
Helsinki, Finland
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Tampere University Hospital; Hematology
Tampere, Finland
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Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
Angers Cedex 9, France
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Hopital Claude Huriez; Hematologie
Lille, France
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Institut J Paoli I Calmettes; Onco Hematologie 2
Marseille, France
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Hopital Hotel Dieu Et Hme;Hopital De Jour
Nantes, France
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Hopital Saint Louis; Oncologie Medicale
Paris, France
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HOPITAL SAINT ANTOINE;Hematologie Clinique
Paris, France
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Hopital De Haut Leveque; Hematologie Clinique
Pessac, France
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Centre Hospitalier Lyon Sud; Hematolgie
Pierre Benite, France
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IUCT Oncopole; Hematologie
Toulouse, France
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Hopitaux De Brabois; Hematologie Medecine Interne
Vandoeuvre Les Nancy, France
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Uniklinik RWTH Aachen; Med. Klinik IV; Klinik f r H matologie, Onkologie, H mostaseologie und Stammz
Aachen, Germany
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Universit tsklinikum Bonn; Med. Klinik u. Poliklinik III; H matologie, Onkologie und Rheumatologie
Bonn, Germany
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Klinikum Braunschweig; Medizinische Klinik III; Klinik f r H matologie und Onkologie
Braunschweig, Germany
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Klinikum Chemnitz gGmbH Krankenhaus K chwald Klinik f.Innere Medizin III
Chemnitz, Germany
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Universit tsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, Germany
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University Clinic Essen, WTZ-H matologie
Essen, Germany
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Universit tsklinikum Hamburg-Eppendorf; Med. II. Klinik
Hamburg, Germany
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Medizinische Hochschule; Zentrum Innere Medizin; Abt. H matologie u. Onkologie
Hannover, Germany
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Klinik der Uni zu K ln; I. Med. Klinik
Köln, Germany
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Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
Mainz, Germany
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Universit tsklinikum Marburg Zentrum f. Innere Medizin
Marburg, Germany
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Soroka Medical Center; Hematology Deptartment
Beer Sheva, Israel
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Shaare Zedek Medical Center; Hematology Dept.
Jerusalem, Israel
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Hadassah Ein Karem Hospital; Haematology
Jerusalem, Israel
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Rabin Medical Center-Beilinson Campus;Hematology-Oncology
Petach Tikva, Israel
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Sheba Medical Center
Ramat Gan, Israel
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Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, Israel
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Assuta Medical Centre, Hematology; Hematology
Tel Aviv, Israel
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Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Italy
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Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
Bologna, Italy
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Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
Ravenna, Italy
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A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Italy
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Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
Roma, Italy
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IRCCS AOU S.Martino; Clinica Ematologica
Genova, Italy
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Ospedale San Raffaele, IRCCS
Milano, Italy
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A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO), Italy
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A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino, Italy
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Ospedale Businco; Ematologia
Cagliari, Italy
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AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello; Dip. Ematologia e Oncologia
Palermo, Italy
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Az. Osp. Di Careggi; Divisione Di Ematologia
Firenze, Italy
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Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Italy
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Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Samsung Medical Center
Seoul, Korea, Republic of
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Seoul St Mary's Hospital
Seoul, Korea, Republic of
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Academisch Medisch Centrum; Hematologie
Amsterdam, Netherlands
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Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
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Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, New Zealand
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Canterbury Health Laboratories; Haematology
Christchurch, New Zealand
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Haukeland Universitetssjukehus; Klinisk forskningspost
Bergen, Norway
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Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway
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Kirov State Inst. of Hematology & Blood Transfusion
Kirov, Russian Federation
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"Hematological Scientific Center
Moscow, Russian Federation
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St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint-Petersburg, Russian Federation
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FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health
Sankt-Petersburg, Russian Federation
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Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona, Spain
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Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, Spain
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Hospital Cl nic i Provincial; Servicio de Hematolog a y Oncolog a
Barcelona, Spain
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Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, Spain
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Reference Study ID Number: WO29519 ...

Hospital Universitario Virgen del Rocio
Sevilla, Spain
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Hospital Universitario la Fe; Servicio de Hematologia
Valencia, Spain
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Universit tsspital Basel; H matologie
Basel, Switzerland
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Inselspital Bern; Medizinische Onkologie
Bern, Switzerland
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Universit tsspital Z rich; Klinik f r H matologie
Zürich, Switzerland
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University Hospital of Wales
Cardiff, United Kingdom
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Reference Study ID Number: WO29519 ...

St Bartholomew's Hospital
London, United Kingdom
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Reference Study ID Number: WO29519 ...

Christie Hospital NHS Trust
Manchester, United Kingdom
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Reference Study ID Number: WO29519 ...

Nottingham City Hospital; Oncology
Nottingham, United Kingdom
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Reference Study ID Number: WO29519 ...

Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
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