<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/NCT02985190</url>
  </required_header>
  <id_info>
    <org_study_id>GFM-AZA-SAID</org_study_id>
    <secondary_id>2016-000918-30</secondary_id>
    <nct_id>NCT02985190</nct_id>
  </id_info>
  <brief_title>A Study of Azacitidine in Myelodysplastic Syndrome (MDS) Associated to Systemic Auto-immune and Inflammatory Disorders</brief_title>
  <official_title>A Phase II Study of Efficacy and Tolerance of Azacitidine (AZA) In MDS-associated Steroid Dependent/Refractory Systemic Auto-immune and Inflammatory Disorders (SAID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Francophone des Myelodysplasies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Francophone des Myelodysplasies</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a phase II of effcicacy and tolerance of azacitidine in patients with&#xD;
      myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and&#xD;
      inflammatory disorders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will be a prospective French nationwide study analyzing the effect of treatment&#xD;
      with azacitidine in patients with MDS-associated SAID with steroid dependence and/or&#xD;
      resistance, and its correlation with possible changes in immunological parameters&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 2, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response rate of Myelodysplastic syndrome and systemic autoimmune and inflammatory diseases (SAID)</measure>
    <time_frame>6 months</time_frame>
    <description>Overall response rate (including partial and complete response) of systemic autoimmune and inflammatory diseases associated with Myelodysplastic syndrome after 6 cycles of azacitidine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treament-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of participants with treament-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>Overall survival</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>MDS</condition>
  <condition>Systemic Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>Azacitidine 75mg/m²/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azacitidine 75mg/m²/j subcutaneously daily for 7 days every 4 weeks for a minimum of 6 cycles (unless overt disease progression, especially to Acute Myeloid Leukemia (AML) occure before 6 cycles) Azacitidine will be continued after 6 cycles&#xD;
in patients with hematological response of myelodysplastic syndrome to azacitidine according to IWG2006 criteria by 6 cycles (Complete Response (CR), Partial Response (PR), marrow Complete Response (CRm), stable disease with Hematological Improvment (HI)), for another 6 cycles&#xD;
in patients with complete or partial response of Systemic Auto-Immune Disorders (SAID) after 6 cycles of Azacitidine, even if Myelodysplastic Syndrome remains only stable per IWG2006 criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Azacitidine at 75mg/m²/j for 7 days.</description>
    <arm_group_label>Azacitidine 75mg/m²/day</arm_group_label>
    <other_name>Vidaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must understand and voluntarily sign the informed consent form&#xD;
&#xD;
          -  Age 18 years at the time of signing the informed consent form&#xD;
&#xD;
          -  Must be able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
          -  MDS or CMML or AML with 20-30% marrow blasts using 2008 WHO classification, with any&#xD;
             of the following characteristics :&#xD;
&#xD;
               1. IPSS intermediate 2 or high, including AML with 20 to 30% marrow blasts and CMML&#xD;
                  with WBC&lt;13G/L and marrow blasts &gt;10%,&#xD;
&#xD;
               2. IPSS low or int 1 in need of treatment (transfusion dependent anemia resistant to&#xD;
                  ESAs and/or platelets below 30 G/l or below 50 G/l with bleeding or platelet&#xD;
                  transfusion requirement, and/or ANC &lt; 0.5 G/l with infectious complications)&#xD;
&#xD;
               3. Documented (by cytogenetic or molecular analysis) MDS /CMML not meeting those&#xD;
                  criteria, but with at least one significant cytopenia (Hb &lt;10 g/dl, platelets&#xD;
                  &lt;50G/l, ANC &lt;1 G/l). In this situation, the underlying SAID should be severe and&#xD;
                  have resisted to a second line treatment (following steroids), if such treatment&#xD;
                  can be proposed for this particular SAID. Those cases should be discussed prior&#xD;
                  to inclusion with the trial sponsors complications)&#xD;
&#xD;
          -  SAID-associated with MDS defined according to usual international criteria for each&#xD;
             SAID (ie ACR criteria for systemic lupus, Chapel Hill classification for systemic&#xD;
             vasculitis, etc…)&#xD;
&#xD;
          -  Steroid dependence and/or resistance of SAID (steroid dependence being defined as the&#xD;
             impossibility to decrease steroids during at least 2 months below 15 mg/day; steroid&#xD;
             resistance as no response of SAID to at least 1 mg/kg/day of prednisone equivalent&#xD;
             during one month)&#xD;
&#xD;
          -  Ineligibility for allogeneic stem cell transplantation during the following 12 months&#xD;
&#xD;
          -  Wash-out at least 6 months since a previous treatement with Lenalidomide&#xD;
&#xD;
          -  No previous use of hypomethylating agents&#xD;
&#xD;
          -  Life expectancy ≥ 6 months&#xD;
&#xD;
          -  Adequate liver function (serum transaminases ≤ 3N)&#xD;
&#xD;
          -  Adequate renal function (creatinine clearance with MDRD formula &gt; 30 ml/min)&#xD;
&#xD;
          -  Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically&#xD;
             sterile) must :&#xD;
&#xD;
               -  Have a negative serum or urine pregnancy test within 2 weeks prior to beginning&#xD;
                  treatment on this study. Lactating patients are excluded.&#xD;
&#xD;
               -  Agree to use, and to be able to comply with, effective contraception without&#xD;
                  interruption, 4 weeks before starting study drug throughout the entire duration&#xD;
                  study drug therapy (including doses interruptions) and for 3 months after the end&#xD;
                  of the study drug therapy.&#xD;
&#xD;
          -  Male patients must :&#xD;
&#xD;
               -  Agree the need for the use of a condom if engaged in sexual activity with a woman&#xD;
                  of childbearing potential during the entire period of treatment, even if&#xD;
                  disruption of treatment and during 3 months after end of treatment.&#xD;
&#xD;
               -  Agree to learn about the procedures for preservation of sperm before starting&#xD;
                  treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IPSS low and intermediate-1 not meeting the criteria described above&#xD;
&#xD;
          -  Creatinine clearance with MDRD formula &lt; 30 ml/min&#xD;
&#xD;
          -  Serum total bilirubin, or serum transaminases &gt; 3.0 x upper limit of normal (ULN)&#xD;
             (except for unconjugated hyperbilirubinemia due to Gilbert's disease or secondary to&#xD;
             MDS)&#xD;
&#xD;
          -  Known hypersensitivity to the active substance or to any of the excipients of AZA&#xD;
&#xD;
          -  History of severe congestive heart failure, clinically unstable cardiac or pulmonary&#xD;
             disease&#xD;
&#xD;
          -  Previous treatment with hypomethylating agents&#xD;
&#xD;
          -  Life-expectancy of less than six months because of another debilitating disease&#xD;
&#xD;
          -  Uncontrolled invasive fungal infection at time of registration or active serious&#xD;
             infection not controlled by oral or intravenous antibiotics&#xD;
&#xD;
          -  Known positive for HIV or acute infectious hepatitis, type B or C&#xD;
&#xD;
          -  Any serious medical condition or psychiatric illness that will prevent the subject&#xD;
             from signing the informed consent form or will place the subject at unacceptable risk&#xD;
             if he/she participates in the study.&#xD;
&#xD;
          -  Active cancer or prior history of malignancy other than MDS (except basal cell or&#xD;
             squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the&#xD;
             subject has been free of disease for ≥ 3 years&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  No affiliation to an insurance system&#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_official>
    <last_name>Arsene MEKINIAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Antoine Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olivier FAIN, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Antoine Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre FENAUX, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Saint-Louis Hospital, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens cedex 01</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers cedex 9</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Victor Dupouy</name>
      <address>
        <city>Argenteuil</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Henri Duffaut d'Avignon</name>
      <address>
        <city>Avignon</city>
        <zip>84000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de la Côte Basque</name>
      <address>
        <city>Bayonne cedex</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Franche-Comté</name>
      <address>
        <city>Belfort</city>
        <zip>90015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Boulogne Sur Mer</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest - Hôpital Morvan</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH René Dubos</name>
      <address>
        <city>Cergy-Pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier William Morey</name>
      <address>
        <city>Chalon-sur-Saône</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHSF Gilles de Corbeil</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU François Mitterrand</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble cedex 09</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier de la Rochelle Ré Aunis</name>
      <address>
        <city>La Rochelle</city>
        <zip>17000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Le Mans</name>
      <address>
        <city>Le Mans cedex 09</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Victor Hugo - Centre Jean Bernard</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Lens</name>
      <address>
        <city>Lens</city>
        <zip>62307</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Claude Huriez</name>
      <address>
        <city>Lille cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Vincent de Paul</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Limoges - Hôpital Dupuytren</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Meaux</name>
      <address>
        <city>Meaux cedex</city>
        <zip>77104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Mont de Marsan</name>
      <address>
        <city>Mont-de-Marsan</city>
        <zip>40000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Beausoleil</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Montpellier - Service de Médecine Interne</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Service d'hématologie Oncologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Hôtel Dieu</name>
      <address>
        <city>Nantes cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Catherine de Sienne</name>
      <address>
        <city>Nantes</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Archet 1</name>
      <address>
        <city>Nice cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nîmes</name>
      <address>
        <city>Nîmes cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine - Service de Médecine Interne</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de La Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine - Service d'Hématologie Clinique</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Joffre</name>
      <address>
        <city>Perpignan</city>
        <zip>66 046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Haut-Lévèque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Annecy Genevois</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital PONTCHAILLOU</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Rochefort</name>
      <address>
        <city>Rochefort</city>
        <zip>17301</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrer Hospitalier de Roubaix</name>
      <address>
        <city>Roubaix</city>
        <zip>59056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Yves Le Foll</name>
      <address>
        <city>Saint-Brieuc</city>
        <zip>22000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IUCT Oncopole</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Troyes</name>
      <address>
        <city>Troyes</city>
        <zip>10003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Valence</name>
      <address>
        <city>Valence</city>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brabois</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Azacitidine</keyword>
  <keyword>MDS</keyword>
  <keyword>Systemic auto-immune and inflammatory disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</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/NCT02985190
org study id: GFM-AZA-SAID
secondary id: 2016-000918-30
nct id: NCT02985190
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a phase II of effcicacy and tolerance of azacitidine in patients with
      myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and
      inflammatory disorders
This trial will be a prospective French nationwide study analyzing the effect of treatment
      with azacitidine in patients with MDS-associated SAID with steroid dependence and/or
      resistance, and its correlation with possible changes in immunological parameters
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate of Myelodysplastic syndrome and systemic autoimmune and inflammatory diseases (SAID)
time frame: 6 months
description: Overall response rate (including partial and complete response) of systemic autoimmune and inflammatory diseases associated with Myelodysplastic syndrome after 6 cycles of azacitidine
measure: Number of participants with treament-related adverse events as assessed by CTCAE v4.0
time frame: up to 52 weeks
description: Number of participants with treament-related adverse events as assessed by CTCAE v4.0
measure: Overall survival
time frame: 24 months
description: Overall survival
arm group label: Azacitidine 75mg/m²/day
arm group type: Experimental
description: Azacitidine 75mg/m²/j subcutaneously daily for 7 days every 4 weeks for a minimum of 6 cycles (unless overt disease progression, especially to Acute Myeloid Leukemia (AML) occure before 6 cycles) Azacitidine will be continued after 6 cycles
in patients with hematological response of myelodysplastic syndrome to azacitidine according to IWG2006 criteria by 6 cycles (Complete Response (CR), Partial Response (PR), marrow Complete Response (CRm), stable disease with Hematological Improvment (HI)), for another 6 cycles
in patients with complete or partial response of Systemic Auto-Immune Disorders (SAID) after 6 cycles of Azacitidine, even if Myelodysplastic Syndrome remains only stable per IWG2006 criteria
intervention type: Drug
intervention name: Azacitidine
description: Azacitidine at 75mg/m²/j for 7 days.
arm group label: Azacitidine 75mg/m²/day
other name: Vidaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arsene MEKINIAN, MD
role: Principal Investigator
affiliation: Saint Antoine Hospital
last name: Olivier FAIN, PHD
role: Principal Investigator
affiliation: Saint Antoine Hospital
last name: Pierre FENAUX, PHD
role: Study Director
affiliation: Saint-Louis Hospital, Paris, France
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country: France
responsible party type: Sponsor
mesh term: Autoimmune Diseases
mesh term: Azacitidine
sharing ipd: Undecided