<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/NCT02197650</url>
  </required_header>
  <id_info>
    <org_study_id>GRASPALL 2012-10-EAP</org_study_id>
    <nct_id>NCT02197650</nct_id>
  </id_info>
  <brief_title>Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase</brief_title>
  <acronym>EAP</acronym>
  <official_title>Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ERYtech Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ERYtech Pharma</source>
  <brief_summary>
    <textblock>
      Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for&#xD;
      patient unable to receive any other form of Asparaginase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some patients can not be eligible to other clinical trials / program sponsored by Erytech&#xD;
      Pharma but could have a benefit to be treated with GRASPA. Following discussion with French&#xD;
      regulatory authorities, it has been suggested to propose access to GRASPA to patients unable&#xD;
      to receive any other form of L-asparaginase and not eligible to the ongoing study or other&#xD;
      program. This exploratory study should allow it in an &quot;Expended Access Program&quot; framework.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>suspension of erythrocytes encapsulating L-asparaginase</intervention_name>
    <description>Erythrocytes encapsulating L-asparaginase</description>
    <other_name>GRASPA®</other_name>
    <other_name>eryaspase</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ALL de novo or in relapse or refractory&#xD;
&#xD;
          -  Eligible to a chemotherapy treatment including L-asparaginase&#xD;
&#xD;
          -  Known contraindication and/or at risk of toxicity to other L-asparaginase formulation&#xD;
             according to investigator opinion based on information available&#xD;
&#xD;
          -  Patient under 55 years old&#xD;
&#xD;
          -  Patient informed and consent provided (the 2 parents need to consent for children).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to receive GRASPA due to general or visceral conditions&#xD;
&#xD;
               -  Serum creatinine ≥ 2 x ULN unless related to ALL&#xD;
&#xD;
               -  ALT or AST ≥ 3 x ULN unless related to ALL&#xD;
&#xD;
               -  Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN&#xD;
&#xD;
               -  Other serious conditions according to investigator's opinion.&#xD;
&#xD;
          -  Absence of documented serological test for HIV, B and C hepatitis&#xD;
&#xD;
          -  History of grade 3 transfusional incident or any contraindication to receive blood&#xD;
             transfusion&#xD;
&#xD;
          -  Patient under concomitant treatment likely to cause hemolysis&#xD;
&#xD;
          -  Presence of specific anti-erythrocyte antibodies preventing from getting a compatible&#xD;
             erythrocyte concentrate for the patient.&#xD;
&#xD;
          -  Patient undergoing yellow fever vaccination.&#xD;
&#xD;
          -  Patient under phenytoin treatment.&#xD;
&#xD;
          -  Women of childbearing potential without effective contraception as well as pregnant or&#xD;
             breast feeding women.&#xD;
&#xD;
          -  Patient already included in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pr. Yves BERTRAND</last_name>
    <role>Principal Investigator</role>
    <affiliation>IHOP, Lyon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pr. Hervé DOMBRET</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint Louis Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Jean Minjoz - Batiment MEMCP</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille - Hôpital Claude-Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHOP</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Archet 2</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rouen - Hôpital des enfants</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint Etienne Hôpital Nord</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer</name>
      <address>
        <city>Toulouse</city>
        <zip>31100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital BRETONNEAU</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Brabois Enfants</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>May 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ALL L-asparaginase encapsulated erythrocytes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asparaginase</mesh_term>
    <mesh_term>Eryaspase</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/NCT02197650
org study id: GRASPALL 2012-10-EAP
nct id: NCT02197650
lead sponsor: 
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for
      patient unable to receive any other form of Asparaginase.
Some patients can not be eligible to other clinical trials / program sponsored by Erytech
      Pharma but could have a benefit to be treated with GRASPA. Following discussion with French
      regulatory authorities, it has been suggested to propose access to GRASPA to patients unable
      to receive any other form of L-asparaginase and not eligible to the ongoing study or other
      program. This exploratory study should allow it in an "Expended Access Program" framework.
intervention type: Drug
intervention name: suspension of erythrocytes encapsulating L-asparaginase
description: Erythrocytes encapsulating L-asparaginase
other name: GRASPA®
other name: eryaspase
criteria: 
gender: All
minimum age: N/A
maximum age: 55 Years
healthy volunteers: No
last name: Pr. Yves BERTRAND
role: Principal Investigator
affiliation: IHOP, Lyon
last name: Pr. Hervé DOMBRET
role: Principal Investigator
affiliation: Hôpital Saint Louis Paris
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Asparaginase
mesh term: Eryaspase