<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250338</url>
  </required_header>
  <id_info>
    <org_study_id>ARO-013</org_study_id>
    <secondary_id>2017-001600-29</secondary_id>
    <nct_id>NCT03250338</nct_id>
  </id_info>
  <brief_title>Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML</brief_title>
  <official_title>Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arog Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arog Pharmaceuticals, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, multi-center, double-blind, placebo-controlled study designed to&#xD;
      evaluate the efficacy of crenolanib administered following salvage chemotherapy,&#xD;
      consolidation chemotherapy, post bone marrow transplantation and as maintenance in&#xD;
      relapsed/refractory AML subjects with FLT3 activating mutation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2018</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free survival (EFS)</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free Survival (RFS)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission rate (CR)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRD negative complete remission rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">322</enrollment>
  <condition>Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations</condition>
  <arm_group>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Crenolanib following salvage chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo following salvage chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crenolanib</intervention_name>
    <description>Crenolanib will be administered orally</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <other_name>Crenolanib besylate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>HAM regimen&#xD;
FLAG-Ida</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitoxantrone</intervention_name>
    <description>HAM regimen</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo will be administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>FLAG-Ida regimen</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idarubicin</intervention_name>
    <description>FLAG-Ida regimen</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-CSF</intervention_name>
    <description>FLAG-Ida regimen</description>
    <arm_group_label>Crenolanib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016&#xD;
             classification&#xD;
&#xD;
          2. Presence of FLT3-ITD and/or D835 mutation(s)&#xD;
&#xD;
          3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for&#xD;
             AML or refractory or relapsed after second line of treatment for AML&#xD;
&#xD;
          4. Age ≥ 18 years and ≤ 75 years&#xD;
&#xD;
          5. Adequate hepatic function&#xD;
&#xD;
          6. Adequate renal functions&#xD;
&#xD;
          7. ECOG performance status ≤ 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known clinically active central nervous system(CNS) leukemia&#xD;
&#xD;
          2. Severe liver disease&#xD;
&#xD;
          3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)&#xD;
&#xD;
          4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of&#xD;
             quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior&#xD;
             use of hydroxyurea or other palliative treatment for leukocytosis is allowed.&#xD;
&#xD;
          5. Previous treatment with crenolanib or prior participation in clinical trial involving&#xD;
             crenolanib.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eunice Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute, Buffalo, New York, United States, 14263</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>General Contact</last_name>
    <phone>214-593-0500</phone>
    <email>info@arogpharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chatchada Karanes, MD</last_name>
      <phone>626-218-2405</phone>
      <email>CKaranes@coh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UC Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Jonas, MD</last_name>
      <phone>916-734-5959</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jack Hsu, MD</last_name>
      <phone>352-273-7832</phone>
      <email>jack.hsu@medicine.ufl.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongtao Liu, MD</last_name>
      <email>hliu@medicine.bsd.uchicago.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kansas University</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>666160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunil Abhyankar, MD</last_name>
    </contact>
    <investigator>
      <last_name>Sunil Abhyankar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay Yang, MD</last_name>
      <email>yangj@karmanos.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yue Guo, MD</last_name>
    </contact>
    <investigator>
      <last_name>Yue Guo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eunice Wang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Eunice Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupali Bhave, MD</last_name>
      <phone>336-716-5487</phone>
      <email>rbhave@wakehealth.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2R3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Brandwein, M.D.</last_name>
      <phone>780-407-7482</phone>
      <email>jbrandwe@ualberta.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thorsten Braun, MD</last_name>
      <phone>+33(0)-1-48-95-75-05</phone>
      <email>Thorsten.braun@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Yves Cahn, MD</last_name>
      <email>JYCahn@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Center of Versailles (Le Chesnay)</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Rousselot, MD</last_name>
      <phone>+33 (0)1.39.63.86.22</phone>
      <email>phrousselot@ch-versailles.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Claude Huriez - Chru Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Quesnel, MD</last_name>
      <phone>+33 (0)3 20 44 66 40</phone>
      <email>bruno.quesnel@chru-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norbert Vey, MD</last_name>
      <phone>+33491223754</phone>
      <email>veyn@ipc.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes - Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre Peterlin, MD</last_name>
      <phone>+33(0)2.44.76.84.45</phone>
      <email>Pierre.peterlin@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Nice L'Archet</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Cluzeau</last_name>
      <phone>+33(0) 492 035 839</phone>
      <email>cluzeau.thomas@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital St Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuel Raffoux, MD</last_name>
      <phone>01 42 49 96 49</phone>
      <email>emmanuel.raffoux@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud Pigneux, MD</last_name>
    </contact>
    <contact_backup>
      <phone>+ 33 5 57 65 65 11</phone>
      <email>arnaud.pigneux@chu-bordeaux.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69494</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Thomas, MD</last_name>
      <phone>+33 47886 2240</phone>
      <email>xavier.thomas@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria-Pilar Gallego-Hernanz, MD</last_name>
      <phone>+33 (0)5.49.44.30.29</phone>
      <email>Maria-Pilar.Gallego-Hernanz@chu-poitiers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Recher, MD</last_name>
      <phone>+33 0531156355</phone>
      <email>Recher.christian@iuct-oncopole.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathias Hänel, MD</last_name>
      <phone>+49 371 333 44500</phone>
      <email>m.haenel@skc.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Technische Universität Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Rollig, MD</last_name>
      <email>Christoph.Roellig@uniklinikum-dresden.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen (AöR)</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Noppeney, MD</last_name>
      <phone>+49 201 723-84706</phone>
      <email>Richard.noppeney@uk-essen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bjorn Steffen, MD</last_name>
      <phone>+49 69 6301 83654</phone>
      <email>steffen@em.uni-frankfurt.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haifa Kathrin Al-Ali, MD</last_name>
      <phone>+49 345 557 4909</phone>
      <email>haifa.al-ali@uk-halle.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan-Henrik Mikesch, MD</last_name>
      <phone>+49 251 835 2818</phone>
      <email>Jan-Henrik.Mikesch@ukmuenster.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adriano Venditti, MD</last_name>
      <phone>+39 0620903226</phone>
      <email>adriano.venditti@uniroma2.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico Sant'Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Curti, MD</last_name>
      <phone>+39 051 2144074</phone>
      <email>antonio.curti2@unibo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ASST Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chiara Cattaneo, MD</last_name>
      <phone>+39 030 3996269/6416</phone>
      <email>chiara.cattaneo@asst-spedalicivili.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AOU Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Bosi, MD</last_name>
      <phone>+39 0557947476</phone>
      <email>alberto.bosi@unifi.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanni Mertinelli, MD</last_name>
      <phone>+39 0543739480</phone>
      <email>giovanni.martinelli@irst.emr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Fracchiolla, MD</last_name>
      <email>nicola.fracchiolla@policlinico.mi.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabetta Todisco, MD</last_name>
      <phone>+39 0294372920</phone>
      <email>elisabetta.todisco@ieo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS San Raffaele Hospital</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabio Ciceri, MD</last_name>
      <phone>+39 0226434289</phone>
      <email>ciceri.fabio@hsr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aorn Antonio Cardarelli</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicetto Ferrara, MD</last_name>
      <phone>0039-0817472241</phone>
      <email>felicetto.ferrara@aocardarelli.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AOU Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabrizio Pane, MD</last_name>
      <phone>+39 0817462037</phone>
      <email>fabrizio.pane@unina.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AOU Maggiore della Carità</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monia Lunghi, MD</last_name>
      <phone>+39 0321 3732194</phone>
      <email>monia.lunghi@med.uniupo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AO Ospedali Riuniti Villa Sofia-Cervello</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Mulè</last_name>
      <phone>+39 339 352 9159</phone>
      <email>a.mule@villasofia.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AO Ospedali Riuniti Marche Nord</name>
      <address>
        <city>Pesaro</city>
        <zip>61122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Visani, MD</last_name>
      <phone>+39 0721364039</phone>
      <email>giuseppe.visani@ospedalimarchenord.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria delle Croci di Ravenna</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Lanza, MD</last_name>
      <phone>+39 0544285752</phone>
      <email>francesco.lanza@auslromagna.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrizia Chiusolo, MD</last_name>
      <phone>+39(0)630154968</phone>
      <email>patrizia.chiusolo@unicatt.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano D'Ardia, MD</last_name>
      <phone>+39 0116335611</phone>
      <email>sdardia@cittadellasalute.to.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AO Ordine Mauriziano di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Saglio, MD</last_name>
      <phone>+39 0115082175</phone>
      <email>giuseppe.saglio@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Policlinico GB Rossi, University Hospital Verona</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianpaolo Nadali, MD</last_name>
      <phone>+39-(0)45-8124420</phone>
      <email>gianpaolo.nadali@univr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AULSS n 8 Berica Ospedale San Bortolo</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eros Di Bona, MD</last_name>
      <phone>+39-0444-753518</phone>
      <email>eros.dibona@aulss8.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital U. Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Antonio Perez Simon, MD</last_name>
      <phone>34 95 501 3273</phone>
      <email>josea.perez.simon.sspa@juntadeandalucia.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias (HUCA)</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teresa Bernal del Castillo, MD</last_name>
      <phone>00 34 618 75 39 04</phone>
      <email>bernaldelcastillo@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruna</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor Noriega Concepcion, MD</last_name>
      <phone>34 981178055</phone>
      <email>victor.noriega.concepcion@sergas.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>San Pedro de Alcantara Hospital</name>
      <address>
        <city>Cáceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Bergua Bergues, MD</last_name>
      <phone>+34 927 62 15 40</phone>
      <email>jmberguaburg@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Reina Sofia University Hospital</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josefina Serrano Lopez, MD</last_name>
      <phone>+ 34 607680781</phone>
      <email>josefina.serrano@iname.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Donostia</name>
      <address>
        <city>Donostia San Sebastian</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esther P Santaolalla, MD</last_name>
      <phone>+34 943 00 75 72</phone>
      <email>esther.perezsantaolalla@osakidetza.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pilar Herrera Puente, MD</last_name>
      <phone>34 91 336 8967</phone>
      <email>pherrera.hrc@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Luis Lopez, MD</last_name>
      <phone>+34 622284472</phone>
      <email>JLLopez@quironsalud.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Calbacho Robles, MD</last_name>
      <phone>34 91 390 8652</phone>
      <email>mcalbachorobles@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene S Vadillo, MD</last_name>
      <phone>+34 912071247</phone>
      <email>Irene.sanchezv@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Monsalvo, MD</last_name>
      <phone>+34 915868396</phone>
      <email>silvia.monsalvo@salud.madrid.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Belen Vidriales, MD</last_name>
      <phone>+34923291100</phone>
      <phone_ext>55375</phone_ext>
      <email>mbvidriales@saludcastillayleon.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital U. Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mercedes Colorado Araujo, MD</last_name>
      <phone>34 94 220 2520</phone>
      <email>mcolorado@humv.es; mercedes.colorado@scsalud.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Santiago</name>
      <address>
        <city>Santiago De Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalia A Vence, MD</last_name>
      <phone>+34 981950172</phone>
      <email>natalia.alonso.vence@sergas.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pau Montesinos, MD</last_name>
      <phone>+34 961244000</phone>
      <email>montesinos_pau@gva.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Mitoxantrone</mesh_term>
    <mesh_term>Idarubicin</mesh_term>
    <mesh_term>Crenolanib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250338
org study id: ARO-013
secondary id: 2017-001600-29
nct id: NCT03250338
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, multi-center, double-blind, placebo-controlled study designed to
      evaluate the efficacy of crenolanib administered following salvage chemotherapy,
      consolidation chemotherapy, post bone marrow transplantation and as maintenance in
      relapsed/refractory AML subjects with FLT3 activating mutation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Event-free survival (EFS)
time frame: 3 years
measure: Overall Survival
time frame: 3 years
measure: Relapse-free Survival (RFS)
time frame: 3 years
measure: Complete remission rate (CR)
time frame: 3 years
measure: MRD negative complete remission rate
time frame: 3 years
arm group label: Crenolanib
arm group type: Experimental
description: Crenolanib following salvage chemotherapy
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo following salvage chemotherapy
intervention type: Drug
intervention name: Crenolanib
description: Crenolanib will be administered orally
arm group label: Crenolanib
other name: Crenolanib besylate
intervention type: Drug
intervention name: Cytarabine
description: HAM regimen
FLAG-Ida
arm group label: Crenolanib
arm group label: Placebo
intervention type: Drug
intervention name: Mitoxantrone
description: HAM regimen
arm group label: Crenolanib
arm group label: Placebo
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo will be administered orally
arm group label: Placebo
intervention type: Drug
intervention name: Fludarabine
description: FLAG-Ida regimen
arm group label: Crenolanib
arm group label: Placebo
intervention type: Drug
intervention name: Idarubicin
description: FLAG-Ida regimen
arm group label: Crenolanib
arm group label: Placebo
intervention type: Drug
intervention name: G-CSF
description: FLAG-Ida regimen
arm group label: Crenolanib
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eunice Wang, MD
role: Principal Investigator
affiliation: Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
last name: General Contact
phone: 214-593-0500
email: info@arogpharma.com
facility: 
status: Recruiting
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country: Canada
country: France
country: Germany
country: Italy
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Fludarabine
mesh term: Mitoxantrone
mesh term: Idarubicin
mesh term: Crenolanib