<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/NCT03263767</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0435</org_study_id>
    <nct_id>NCT03263767</nct_id>
  </id_info>
  <brief_title>Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC</brief_title>
  <acronym>CYRIC</acronym>
  <official_title>Phase II Study Testing Prophylaxis Feasibility of Graft Versus Host Disease With Only High Dose Cyclophosphamide Post-transplantation for Patients Eligible to a Reduced-intensity Conditioning Regiment Prior to Allogenic Transplantation With a Compatible Familial or Non-familial Donor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute or chronic graft versus host disease is still the major complication of stem cells&#xD;
      transplantation regarding morbidity and mortality.&#xD;
&#xD;
      Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and&#xD;
      +4) not only for patients with HLA- haploidentical donor but also for patients with Human&#xD;
      Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease&#xD;
      after transplantation, allowing to consider stopping immunosuppressive treatment after the&#xD;
      transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has&#xD;
      already been completed in myeloablative transplantation in adult patients.&#xD;
&#xD;
      This approach could enable to avoid in the end several complications related to long term&#xD;
      immunosuppressive drugs administration, while promoting quicker immunity recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BALTIMORE conditioning regiment will be used in this study with peripheral stem cell&#xD;
      transplantation and fludarabine will be replaced by clofarabine for myeloid diseases (Acute&#xD;
      Myeloide Leukemia, Myelodysplasia , myelofibrosis, Chronic Myeoloid Leukemia..) because of&#xD;
      better antitumoral activity in this setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Security criteria (MTD)&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">June 21, 2022</completion_date>
  <primary_completion_date type="Actual">October 21, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of grade 3 and 4 acute GVHD cortico-resistant</measure>
    <time_frame>100 days after transplantation</time_frame>
    <description>acute GVHD will be evaluated from International Mount Sinai criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Engraftment</measure>
    <time_frame>one year</time_frame>
    <description>number of days in aplasia (neutrophils&lt; 0.5 Giga/L and platelets&lt;20 G/l, number of transfusions (red blood and platelets)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engraftment</measure>
    <time_frame>one year</time_frame>
    <description>chimerism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease free survival (DFS)</measure>
    <time_frame>one year, the last follow-up visit</time_frame>
    <description>blood and bone marrow analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>one year, the last follow-up visit</time_frame>
    <description>clinical follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>graft and relapse free survival</measure>
    <time_frame>one year</time_frame>
    <description>time between Day O and relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic GVHD</measure>
    <time_frame>one year</time_frame>
    <description>chronic GVHD will be assessed with NCI criteria for evaluation of chronic GVHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non relapse mortality (NRM)</measure>
    <time_frame>last follow-up visit</time_frame>
    <description>number of death unrelated to relapse or disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chimerism</measure>
    <time_frame>1, 2, 3, 6 and 12 months after transplantation</time_frame>
    <description>proportion of full and mixed donor chimerism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune reconstitution</measure>
    <time_frame>3, 6 and 12 months after transplantation</time_frame>
    <description>lymphocytes, monocytes, T4, T8, Natural Killer (NK), B cells rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of ghost factors associated with GVHD</measure>
    <time_frame>one year</time_frame>
    <description>Statistical Models to Identify Subjects with Ghost Prognosis Factors Nguyen JM. 2015</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events of grade 3 and 4 after transplantation</measure>
    <time_frame>one year</time_frame>
    <description>time of occurring and frequency of grade 3 and grade 4 adverse events (CTCAE criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infections frequency</measure>
    <time_frame>one year</time_frame>
    <description>time of occurring and frequency of viral (CytoMegalo Virus, Epstein Barr virus , BKV, adenovirus), bacterial, parasite and yeast infections, evaluated by Polymerase Chain Reaction (PCR), blood and urines cultures, biopsy if applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare OS between patients with ATG and patients without ATG</measure>
    <time_frame>one year, last follow-up visit</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare grade 2-4 and 3-4 acute GVHD between patients with ATG and patients without ATG</measure>
    <time_frame>one year</time_frame>
    <description>acute GVHD will be evaluated from International Mount Sinai criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare chronic GVHD between patients with ATG and patients without ATG</measure>
    <time_frame>one year</time_frame>
    <description>chronic GVHD will be assessed with NCI criteria for evaluation of chronic GVHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare DFS between patients with ATG and patients without ATG</measure>
    <time_frame>one year, last follow-up visit</time_frame>
    <description>DFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare Relapse between patients with ATG and patients without ATG</measure>
    <time_frame>one year, last follow-up visit</time_frame>
    <description>Relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare NRM between patients with ATG and patients without ATG</measure>
    <time_frame>one year, last follow-up visit</time_frame>
    <description>NRM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>compare Infections frequency between patients with ATG and patients without ATG</measure>
    <time_frame>one year</time_frame>
    <description>time of occurring and frequency of viral (CytoMegalo Virus, Epstein Barr virus , BKV, adenovirus), bacterial, parasite and yeast infections, evaluated by Polymerase Chain Reaction (PCR), blood and urines cultures, biopsy if applicable</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Graft Versus Host Disease</condition>
  <arm_group>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with lymphoid hemopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with myeloid hemopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>30 mg/m² Intravenous 5 days from Day-6 to Day-2</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clofarabine</intervention_name>
    <description>30 mg/m² Intravenous 5 days from Day-6 to Day-2</description>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Full body irradiation</intervention_name>
    <description>2 grays at Day-1</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>14 mg/kg intravenous 2 days at Day - 6 and day -5</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>50 mg/kg intravenous 2 days at day +3 and day +4</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
    <other_name>hight dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stem cell transplantation</intervention_name>
    <description>at D0 intraveinous Depending on donor : the stem cells will be extracted from blood (CD34+) or from bone marrow (CD34+ and nuclear cells)</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
    <other_name>graft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nuclear cells</intervention_name>
    <description>CD3+ cells if needed after transplantation</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>LYMPHOID HEMOPATHY without ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY without ATG</arm_group_label>
    <other_name>Donor Lymphocytes Injection (DLI)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thymoglobulin Injectable Product</intervention_name>
    <description>At day -2 2.5 mg/kg for patients inclued after 14 dec 2020</description>
    <arm_group_label>LYMPHOID HEMOPATHY witH ATG</arm_group_label>
    <arm_group_label>MYELOID HEMOPATHY with ATG</arm_group_label>
    <other_name>ATG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults ≤ 70 years old&#xD;
&#xD;
          -  indication to stem cells transplantation with reduced-intensity conditioning regimen&#xD;
&#xD;
          -  with a HLA-compatible familial 10/10 or non-familial donor&#xD;
&#xD;
          -  Written signed informed consent form&#xD;
&#xD;
          -  woman with childbearing potential under efficient control birth method during the&#xD;
             trial and up to 12 months after cyclophosphamide stop&#xD;
&#xD;
          -  men under efficient control birth method during the trial and up to 6 months after&#xD;
             cyclophosphamide stop&#xD;
&#xD;
          -  Negative serology to B and C hepatitis and to HIV&#xD;
&#xD;
          -  Affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Eligible to myeloablative contioning regimen&#xD;
&#xD;
          -  Other progressive malignancy disease or history of prior other malignancy in the last&#xD;
             two years, with the exception of: curatively treated basal cell carcinoma or carcinoma&#xD;
             in situ of the cervix&#xD;
&#xD;
          -  Progressive mental illness disease&#xD;
&#xD;
          -  Pregnant or Breastfeeding woman&#xD;
&#xD;
          -  woman with childbearing potential without any efficient control birth&#xD;
&#xD;
          -  Serious concomitant infection and not controlled&#xD;
&#xD;
          -  Contra-indications to allogenic transplantation, especially:&#xD;
&#xD;
               -  Cardiac: left ventricular ejection fraction &lt;45% assessed by transthoracic&#xD;
                  echography or isotopic method (isotopic gamma-angiography)&#xD;
&#xD;
               -  Respiratory: DLCO limiting fludarabine and busulfan use (DLCO&lt; 40% of theorical&#xD;
                  value)&#xD;
&#xD;
               -  Renal: creatinine clearance &lt; 60ml/min (MDRD method)&#xD;
&#xD;
               -  Hepatic: transaminases &gt;5 Uper Per Normal (UPN) or bilirubin&gt; 2 UPN&#xD;
&#xD;
          -  Contra-indications to cyclophosphamide:&#xD;
&#xD;
               -  Urinary tract infections&#xD;
&#xD;
               -  Acute urothelial toxicity due to cytotoxic chemotherapy or to radiotherapy&#xD;
&#xD;
               -  Obstruction of urines flow&#xD;
&#xD;
               -  Pre-existing hemorrhagic cystitis&#xD;
&#xD;
               -  Yellow fever vaccination&#xD;
&#xD;
          -  Cardiac condition preventing high dose cyclophosphamide utilization :&#xD;
&#xD;
               -  New York Heart Association (NYHA) functional class II, III or IV&#xD;
&#xD;
               -  Rhythmic, valvular or ischemic cardiomyopathy&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient under judicial protection&#xD;
&#xD;
          -  Known or suspected hypersensitivity to cyclophosphamide&#xD;
&#xD;
          -  Known or suspected hypersensitivity to rabbit proteins&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes Uh</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>July 13, 2022</last_update_submitted>
  <last_update_submitted_qc>July 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral haemopoietic stem cell transplant</keyword>
  <keyword>High dose cyclophosphamide</keyword>
  <keyword>acute GVHD</keyword>
  <keyword>allogenic transplantation</keyword>
  <keyword>RIC (reduced-intensity conditioning)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Clofarabine</mesh_term>
    <mesh_term>Thymoglobulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03263767
org study id: RC16_0435
nct id: NCT03263767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Acute or chronic graft versus host disease is still the major complication of stem cells
      transplantation regarding morbidity and mortality.

      Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and
      +4) not only for patients with HLA- haploidentical donor but also for patients with Human
      Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease
      after transplantation, allowing to consider stopping immunosuppressive treatment after the
      transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has
      already been completed in myeloablative transplantation in adult patients.

      This approach could enable to avoid in the end several complications related to long term
      immunosuppressive drugs administration, while promoting quicker immunity recovery.
The BALTIMORE conditioning regiment will be used in this study with peripheral stem cell
      transplantation and fludarabine will be replaced by clofarabine for myeloid diseases (Acute
      Myeloide Leukemia, Myelodysplasia , myelofibrosis, Chronic Myeoloid Leukemia..) because of
      better antitumoral activity in this setting.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of grade 3 and 4 acute GVHD cortico-resistant
time frame: 100 days after transplantation
description: acute GVHD will be evaluated from International Mount Sinai criteria
measure: Engraftment
time frame: one year
description: number of days in aplasia (neutrophils< 0.5 Giga/L and platelets<20 G/l, number of transfusions (red blood and platelets)
measure: Engraftment
time frame: one year
description: chimerism
measure: disease free survival (DFS)
time frame: one year, the last follow-up visit
description: blood and bone marrow analysis
measure: Overall survival (OS)
time frame: one year, the last follow-up visit
description: clinical follow-up
measure: graft and relapse free survival
time frame: one year
description: time between Day O and relapse
measure: chronic GVHD
time frame: one year
description: chronic GVHD will be assessed with NCI criteria for evaluation of chronic GVHD
measure: non relapse mortality (NRM)
time frame: last follow-up visit
description: number of death unrelated to relapse or disease progression
measure: Chimerism
time frame: 1, 2, 3, 6 and 12 months after transplantation
description: proportion of full and mixed donor chimerism
measure: Immune reconstitution
time frame: 3, 6 and 12 months after transplantation
description: lymphocytes, monocytes, T4, T8, Natural Killer (NK), B cells rates
measure: Identification of ghost factors associated with GVHD
time frame: one year
description: Statistical Models to Identify Subjects with Ghost Prognosis Factors Nguyen JM. 2015
measure: Adverse events of grade 3 and 4 after transplantation
time frame: one year
description: time of occurring and frequency of grade 3 and grade 4 adverse events (CTCAE criteria)
measure: Infections frequency
time frame: one year
description: time of occurring and frequency of viral (CytoMegalo Virus, Epstein Barr virus , BKV, adenovirus), bacterial, parasite and yeast infections, evaluated by Polymerase Chain Reaction (PCR), blood and urines cultures, biopsy if applicable
measure: compare OS between patients with ATG and patients without ATG
time frame: one year, last follow-up visit
description: OS
measure: compare grade 2-4 and 3-4 acute GVHD between patients with ATG and patients without ATG
time frame: one year
description: acute GVHD will be evaluated from International Mount Sinai criteria
measure: compare chronic GVHD between patients with ATG and patients without ATG
time frame: one year
description: chronic GVHD will be assessed with NCI criteria for evaluation of chronic GVHD
measure: compare DFS between patients with ATG and patients without ATG
time frame: one year, last follow-up visit
description: DFS
measure: compare Relapse between patients with ATG and patients without ATG
time frame: one year, last follow-up visit
description: Relapse
measure: compare NRM between patients with ATG and patients without ATG
time frame: one year, last follow-up visit
description: NRM
measure: compare Infections frequency between patients with ATG and patients without ATG
time frame: one year
description: time of occurring and frequency of viral (CytoMegalo Virus, Epstein Barr virus , BKV, adenovirus), bacterial, parasite and yeast infections, evaluated by Polymerase Chain Reaction (PCR), blood and urines cultures, biopsy if applicable
arm group label: LYMPHOID HEMOPATHY without ATG
arm group type: Experimental
description: patients with lymphoid hemopathy
arm group label: MYELOID HEMOPATHY without ATG
arm group type: Experimental
description: patients with myeloid hemopathy
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group type: Experimental
description: patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence
arm group label: MYELOID HEMOPATHY with ATG
arm group type: Experimental
description: patients inclued after 14 dec 2020, received a conditionnement regimen with ATG on Day -2 to reduce GVHD GRADE 1-2 incidence
intervention type: Drug
intervention name: Fludarabine
description: 30 mg/m² Intravenous 5 days from Day-6 to Day-2
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
intervention type: Drug
intervention name: Clofarabine
description: 30 mg/m² Intravenous 5 days from Day-6 to Day-2
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
intervention type: Radiation
intervention name: Full body irradiation
description: 2 grays at Day-1
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
intervention type: Drug
intervention name: Cyclophosphamide
description: 14 mg/kg intravenous 2 days at Day - 6 and day -5
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
intervention type: Drug
intervention name: Cyclophosphamide
description: 50 mg/kg intravenous 2 days at day +3 and day +4
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
other name: hight dose
intervention type: Other
intervention name: stem cell transplantation
description: at D0 intraveinous Depending on donor : the stem cells will be extracted from blood (CD34+) or from bone marrow (CD34+ and nuclear cells)
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
other name: graft
intervention type: Other
intervention name: nuclear cells
description: CD3+ cells if needed after transplantation
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: LYMPHOID HEMOPATHY without ATG
arm group label: MYELOID HEMOPATHY with ATG
arm group label: MYELOID HEMOPATHY without ATG
other name: Donor Lymphocytes Injection (DLI)
intervention type: Drug
intervention name: Thymoglobulin Injectable Product
description: At day -2 2.5 mg/kg for patients inclued after 14 dec 2020
arm group label: LYMPHOID HEMOPATHY witH ATG
arm group label: MYELOID HEMOPATHY with ATG
other name: ATG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Graft vs Host Disease
mesh term: Cyclophosphamide
mesh term: Fludarabine
mesh term: Clofarabine
mesh term: Thymoglobulin
sharing ipd: No