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

  • Cancer
  • Leukemia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Cities
  • Aachen
  • Adelaide
  • Amsterdam
  • Angers
  • Auckland
  • Barcelona
  • Basel
  • Bergamo
  • Bergen
  • Birmingham
  • Bologna
  • Bonn
  • Braunschweig
  • Busan
  • Cardiff
  • Chemnitz
  • Concord
  • Dallas
  • Dresden
  • Florence
  • Garran
  • Geelong
  • Genova
  • Graz
  • Great Neck
  • Gwangju
  • Hamilton
  • Hannover
  • Helsinki
  • Houston
  • Jerusalem
  • Köln
  • La Louvière
  • Lille
  • London
  • luik
  • Maastricht
  • Madrid
  • Mainz
  • Manchester
  • Marburg
  • Marseille
  • Melbourne
  • Meldola
  • Milano
  • Moskva
  • Nantes
  • Napoli
  • New York
  • Oslo
  • Panamá
  • Paris
  • Pessac
  • Petah Tikva
  • Philadelphia
  • Pierre-Bénite
  • Pisa
  • Ravenna
  • Roeselare
  • Roma
  • Sanatorio San Luigi
  • Sankt-Peterburg
  • Seoul
  • Sevilla
  • Sutton
  • Tampere
  • Tel Aviv-Yafo
  • Torino
  • Toulouse
  • Udine
  • valhalla
  • València
  • Vandœuvre-lès-Nancy
  • Zürich
Trial Identifier:

NCT02545283 2014-003065-15 WO29519

  • Northwell Health

    11021Great NeckUnited States
  • New York Medical College

    10595valhallaUnited States
  • Ichan School of Medicine at Mount Sinai

    10029New YorkUnited States
  • Abramson Cancer Center; Univ of Pennsylvania

    19104PhiladelphiaUnited States
  • Thomas Jefferson University

    19107PhiladelphiaUnited States
  • Baylor University Medical Center

    75246DallasUnited States
  • M.D. Anderson Cancer Center; Department of Hematology

    77030HoustonUnited States
  • Canberra Hospital; Haematology Department

    2605GarranAustralia
  • Concord Repatriation General Hospital; Haematology

    2139ConcordAustralia
  • Royal Adelaide Hospital; Haematology Clinical Trials

    5000AdelaideAustralia
  • Geelong Hospital; Andrew Love Cancer Centre

    3220GeelongAustralia
  • Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation

    3004MelbourneAustralia
  • Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

    8036GrazAustria
  • CH Jolimont - Lobbes (Jolimont)

    7100La LouvièreBelgium
  • CHU Sart-Tilman

    4000luikBelgium
  • AZ Delta (Campus Rumbeke)

    8800RoeselareBelgium
  • Juravinski Cancer Clinic; Clinical Trials Department

    L8V 5C2HamiltonCanada
  • Helsinki University Central Hospital; Hematology

    00280HelsinkiFinland
  • Tampere University Hospital; Hematology

    33520TampereFinland
  • Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

    AngersFrance
  • Hopital Claude Huriez; Hematologie

    59000LilleFrance
  • Institut J Paoli I Calmettes; Onco Hematologie 2

    13009MarseilleFrance
  • Hopital Hotel Dieu Et Hme;Hopital De Jour

    44000NantesFrance
  • Hopital Saint Louis; Oncologie Medicale

    75010ParisFrance
  • HOPITAL SAINT ANTOINE;Hematologie Clinique

    75012ParisFrance
  • Hopital De Haut Leveque; Hematologie Clinique

    33600PessacFrance
  • Centre Hospitalier Lyon Sud; Hematolgie

    69495Pierre-BéniteFrance
  • IUCT Oncopole; Hematologie

    31100ToulouseFrance
  • Hopitaux De Brabois; Hematologie Medecine Interne

    54500Vandœuvre-lès-NancyFrance
  • Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

    52074AachenGermany
  • Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

    53127BonnGermany
  • Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

    38114BraunschweigGermany
  • Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

    09113ChemnitzGermany
  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

    01307DresdenGermany
  • Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

    30625HannoverGermany
  • Klinik der Uni zu Köln; I. Med. Klinik

    50937KölnGermany
  • Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

    55131MainzGermany
  • Universitätsklinikum Marburg Zentrum f. Innere Medizin

    35043MarburgGermany
  • Shaare Zedek Medical Center; Hematology Dept.

    9103102JerusalemIsrael
  • Hadassah Ein Karem Hospital; Haematology

    9112001JerusalemIsrael
  • Rabin Medical Center-Beilinson Campus;Hematology-Oncology

    4941492Petah TikvaIsrael
  • Ichilov Sourasky Medical Center; Heamatology

    Tel Aviv-YafoIsrael
  • Ospedale Cardarelli; Divisione Di Ematologia

    80131NapoliItaly
  • Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

    40138BolognaItaly
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

    47014MeldolaItaly
  • Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

    48121RavennaItaly
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

    33100UdineItaly
  • Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

    00133RomaItaly
  • IRCCS AOU S.Martino; Clinica Ematologica

    16132GenovaItaly
  • ASST PAPA GIOVANNI XXIII; Ematologia

    24127BergamoItaly
  • Ospedale San Raffaele, IRCCS

    20132MilanoItaly
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    20162MilanoItaly
  • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

    10043Sanatorio San LuigiItaly
  • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

    10126TorinoItaly
  • Az. Osp. Di Careggi; Divisione Di Ematologia

    50134FlorenceItaly
  • Ospedale Santa Chiara; Unita Operativa Di Ematologia

    56126PisaItaly
  • Pusan National University Hospital

    49241BusanSouth Korea
  • Chonnam National University Hwasun Hospital

    501-190GwangjuSouth Korea
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Samsung Medical Center

    06351SeoulSouth Korea
  • Seoul St Mary's Hospital

    137-044SeoulSouth Korea
  • Academisch Medisch Centrum; Hematologie

    1105 AZAmsterdamNetherlands
  • Academisch Ziekenhuis Maastricht

    6229 HXMaastrichtNetherlands
  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

    1023AucklandNew Zealand
  • Haukeland Universitetssjukehus; Klinisk forskningspost

    5021BergenNorway
  • Oslo Universitetssykehus HF, Rikshospitalet

    0372OsloNorway
  • Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología

    PanamáPanama
  • "Hematological Scientific Center

    119571MoskvaRussia
  • St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

    197022Sankt-PeterburgRussia
  • FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

    197341Sankt-PeterburgRussia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia

    08025BarcelonaSpain
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    08036BarcelonaSpain
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia

    28041MadridSpain
  • Hospital Universitario Virgen del Rocio

    41013SevillaSpain
  • Hospital Universitario la Fe; Servicio de Hematologia

    46026ValènciaSpain
  • Universitätsspital Basel; Hämatologie

    4031BaselSwitzerland
  • Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

    8091ZürichSwitzerland
  • Birmingham Heartlands Hospital

    B9 5SSBirminghamUnited Kingdom
  • University Hospital of Wales

    CF14 4XWCardiffUnited Kingdom
  • St Bartholomew's Hospital

    EC1A 7BELondonUnited Kingdom
  • Christie Hospital NHS Trust

    M20 4BXManchesterUnited Kingdom
  • Royal Marsden NHS Foundation Trust

    SM2 5PTSuttonUnited Kingdom
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial 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.

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT02545283, WO29519, 2014-003065-15 Trial Identifier
    Cytarabine, Idasanutlin, Placebo Treatments
    Leukemia, Myeloid, Acute Condition
    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)

    Eligibility Criteria

    All Gender
    ≥ 18 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
    • No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
    • Eastern Cooperative Oncology Group performance status of 0 to 2
    • Adequate hepatic and renal function
    • White blood cell (WBC) count at randomization less than or equal to (</=) 50000 cells per cubic millimeter (/mm^3)
    Exclusion Criteria
    • First relapsed participants aged less than (<) 60 years with first CR duration greater than (>) 1 year
    • Participants with prior documented antecedent hematological disorder (AHD)
    • AML secondary to any prior chemotherapy unrelated to leukemia
    • Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
    • Participants who have received allogeneic HSCT within 90 days prior to randomization
    • Participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
    • Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
    • Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
    • Participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
    • Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
    • Participants with extramedullary AML with no evidence of systemic involvement
    • Pregnant or breastfeeding participants

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