<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/NCT03751917</url>
  </required_header>
  <id_info>
    <org_study_id>APL0618</org_study_id>
    <nct_id>NCT03751917</nct_id>
  </id_info>
  <brief_title>Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia</brief_title>
  <acronym>APL0618</acronym>
  <official_title>A Long-Term Retrospective and Prospective Safety Study of Arsenic Trioxide in Patients With Newly Diagnosed, Low- to Intermediate-Risk Acute Promyelocytic Leukemia (APL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gruppo Italiano Malattie EMatologiche dell'Adulto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gruppo Italiano Malattie EMatologiche dell'Adulto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and&#xD;
      manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough&#xD;
      information on the incidence of long-term side effects.&#xD;
&#xD;
      This study, as well as other similar studies conducted around Europe, will focus on following&#xD;
      patients treated with this therapy on a long-term basis.&#xD;
&#xD;
      Once all studies in Europe will be concluded, all data will be analyzed together.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Considering the clear therapeutic advantage associated with ATRA+ATO combination therapy and&#xD;
      the more favorable and overall manageable safety profile compared to ATRA+chemotherapy, the&#xD;
      benefits of the combination in the first-line indication do appear to overweigh the risks.&#xD;
&#xD;
      However, no information regarding the actual adverse event (AE) incidence and the long-term&#xD;
      toxicity of ATRA+ATO is available at present and therefore, as a postmarketing commitment,&#xD;
      TEVA (the Company holding the Marketing Authorisation of Trisenox® (Arsenic trioxide)) is&#xD;
      setting up a long-term safety cohort study of Trisenox in newly diagnosed low- to&#xD;
      intermediate-risk APL patients retrospectively analyzing data from APL disease registries all&#xD;
      around Europe.&#xD;
&#xD;
      As a result, this observational study is part of the retrospective PASS Study (A&#xD;
      Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First&#xD;
      Line Low-to Intermediate-Risk Acute Promyelocytic Leukaemia Patients) that will use data from&#xD;
      multinational APL disease registries in Europe. The present study will focus on Italian&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of grade III/IV (Common Terminology Criteria for Adverse Events (CTCAE) v4.03) adverse events of special interest (AESI).</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
    <description>AESI are, among others: differentiation syndrome, creatinine, bilirubin, neurotoxicity, aspartate amino transferase/alanine amino transferase (ASAT/ALAT) ratio, haemorrhage, sepsis, QTc prolongation, cardiac events including congestive heart failure (CHF).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of unexpected serious adverse events (SAEs).</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
    <description>Including grading and relationship as documented in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients developing secondary malignancies.</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients developing therapy-related myelodysplastic syndrome (tMDS).</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients developing acute myeloid leukemia (tAML).</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who die.</measure>
    <time_frame>At a maximum of 5 years from study entry</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Promyelocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>APL patients</arm_group_label>
    <description>The study will be conducted using multinational data from disease registries for APL. The study participants will consist of patients with newly diagnosed, low-to intermediate-risk APL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arsenic Trioxide</intervention_name>
    <description>This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.</description>
    <arm_group_label>APL patients</arm_group_label>
    <other_name>ATRA+ATO</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The Source Population for the study is patients included in existing multinational disease&#xD;
        registries for APL in Europe. APL registries collect real-world data on APL demographics&#xD;
        and provide information on disease characteristics, treatment patterns and long-term&#xD;
        effects. Participating physicians are not subject to any instructions with regard to the&#xD;
        diagnosis and therapy of their patients. All patient treatment is carried out within&#xD;
        routine clinical practice at the discretion of the physician and according to existing&#xD;
        treatment guidelines.&#xD;
&#xD;
        Data will be extracted from the registries for all patients meeting the above inclusion and&#xD;
        exclusion criteria to provide the study population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  APL diagnosis based on cytological criteria and confirmed by the presence of the&#xD;
             (15;17) translocation and/or the presence of the PML/RARA rearrangement (with the&#xD;
             determination of the breakpoint subtype).&#xD;
&#xD;
          -  Newly diagnosed low- to intermediate-risk APL (white blood cells [WBC] count&#xD;
             ≤10x103/µL)&#xD;
&#xD;
          -  First line treatment with ATRA+ATO&#xD;
&#xD;
          -  Aged 18 years or above&#xD;
&#xD;
          -  Signed informed consent, if applicable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk APL (WBC count &gt; 10x103/µL)&#xD;
&#xD;
          -  APL relapse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Paola Fazi</last_name>
    <phone>+39 0670390514</phone>
    <email>p.fazi@gimema.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Enrico Crea</last_name>
    <phone>+39 0670390514</phone>
    <email>e.crea@gimema.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia</name>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorella Depaoli</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paola Carluccio</last_name>
      <phone>3383401921</phone>
      <email>paola.carluccio@policlinico.ba.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Specchia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera - Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rambaldi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asst Degli Spedali Civili Di Brescia - Uo Ematologia</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erika Borlenghi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudio Romani</last_name>
      <phone>3387938629</phone>
      <email>claromani@tiscali.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CTMO - Ematologia - Ospedale &quot;Binaghi&quot;</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cabras</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo</name>
      <address>
        <city>Castelfranco Veneto</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Sartori</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Molica</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Germana Beltrami</last_name>
      <phone>3495215547</phone>
      <email>germana.beltrami@hsanmartino.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Angelucci</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cortelezzi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabio Ciceri</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda &quot; Ca Granda&quot; - SC Ematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valentina Mancini</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera &quot;S.Gerardo&quot;</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pioltelli</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Napoli Azienda Ospedaliera di Rilievo Nazionale &quot;A. Cardarelli&quot;</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicetto Ferrara</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti &quot;Villa Sofia-Cervello&quot;</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Fabbiano</last_name>
      <phone>3341149462</phone>
      <email>ffabbiano@libero.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>U.O. Ematologia Clinica - Azienda USL di Pescara</name>
      <address>
        <city>Pescara</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pescara</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Teresa Voso</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrizia Chiusolo</last_name>
      <phone>3355267999</phone>
      <email>patrizia.chiusolo@Unicatt.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universita' &quot;Sapienza&quot; - Dip Biotecnologie Cellulari - Divisione di Ematologia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Foà</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>De Stefano</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Università Degli Studi Di Roma &quot;Sapienza&quot; - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Breccia</last_name>
      <phone>3398972422</phone>
      <email>breccia@bce.uniroma1.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorella Melillo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano D'ardia</last_name>
      <phone>3484745268</phone>
      <email>sdardia@cittadellasalute.to.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vitolo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia</name>
      <address>
        <city>Vicenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eros Di bona</last_name>
      <phone>3483429883</phone>
      <email>eros.dibona@aulss8.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ULSS N.6 Osp. S. Bortolo</name>
      <address>
        <city>Vicenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ruggeri</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.gimema.it</url>
    <description>GIMEMA Foundation website</description>
  </link>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>December 31, 2021</last_update_submitted>
  <last_update_submitted_qc>December 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute promyelocytic leukemia</keyword>
  <keyword>Adults</keyword>
  <keyword>Arsenic trioxide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Promyelocytic, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arsenic Trioxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03751917
org study id: APL0618
nct id: NCT03751917
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and
      manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough
      information on the incidence of long-term side effects.

      This study, as well as other similar studies conducted around Europe, will focus on following
      patients treated with this therapy on a long-term basis.

      Once all studies in Europe will be concluded, all data will be analyzed together.
Considering the clear therapeutic advantage associated with ATRA+ATO combination therapy and
      the more favorable and overall manageable safety profile compared to ATRA+chemotherapy, the
      benefits of the combination in the first-line indication do appear to overweigh the risks.

      However, no information regarding the actual adverse event (AE) incidence and the long-term
      toxicity of ATRA+ATO is available at present and therefore, as a postmarketing commitment,
      TEVA (the Company holding the Marketing Authorisation of Trisenox® (Arsenic trioxide)) is
      setting up a long-term safety cohort study of Trisenox in newly diagnosed low- to
      intermediate-risk APL patients retrospectively analyzing data from APL disease registries all
      around Europe.

      As a result, this observational study is part of the retrospective PASS Study (A
      Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First
      Line Low-to Intermediate-Risk Acute Promyelocytic Leukaemia Patients) that will use data from
      multinational APL disease registries in Europe. The present study will focus on Italian
      patients.
observational model: Cohort
time perspective: Other
measure: Number of grade III/IV (Common Terminology Criteria for Adverse Events (CTCAE) v4.03) adverse events of special interest (AESI).
time frame: At a maximum of 5 years from study entry
description: AESI are, among others: differentiation syndrome, creatinine, bilirubin, neurotoxicity, aspartate amino transferase/alanine amino transferase (ASAT/ALAT) ratio, haemorrhage, sepsis, QTc prolongation, cardiac events including congestive heart failure (CHF).
measure: Number of unexpected serious adverse events (SAEs).
time frame: At a maximum of 5 years from study entry
description: Including grading and relationship as documented in the study.
measure: Number of patients developing secondary malignancies.
time frame: At a maximum of 5 years from study entry
measure: Number of patients developing therapy-related myelodysplastic syndrome (tMDS).
time frame: At a maximum of 5 years from study entry
measure: Number of patients developing acute myeloid leukemia (tAML).
time frame: At a maximum of 5 years from study entry
measure: Number of patients who die.
time frame: At a maximum of 5 years from study entry
arm group label: APL patients
description: The study will be conducted using multinational data from disease registries for APL. The study participants will consist of patients with newly diagnosed, low-to intermediate-risk APL.
intervention type: Drug
intervention name: Arsenic Trioxide
description: This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.
arm group label: APL patients
other name: ATRA+ATO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paola Fazi
phone: +39 0670390514
email: p.fazi@gimema.it
last name: Enrico Crea
phone: +39 0670390514
email: e.crea@gimema.it
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Italy
url: http://www.gimema.it
description: GIMEMA Foundation website
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Promyelocytic, Acute
mesh term: Arsenic Trioxide
sharing ipd: Undecided