<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/NCT03774082</url>
  </required_header>
  <id_info>
    <org_study_id>CINC424G12201</org_study_id>
    <secondary_id>2018-003296-35</secondary_id>
    <nct_id>NCT03774082</nct_id>
  </id_info>
  <brief_title>Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant</brief_title>
  <official_title>A Phase II Open-label, Single-arm, Multi-center Study of Ruxolitinib Added to Corticosteroids in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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 open-label, single-arm, Phase II multi-center study will enroll approximately 42&#xD;
      subjects and investigate the activity, pharmacokinetics and safety of ruxolitinib added to&#xD;
      the subject's immunosuppressive regimen among infants, children, and adolescents aged ≥28&#xD;
      days to &lt;18 years old with either moderate to severe treatment-naive cGvHD or SR-cGvHD.&#xD;
      Subjects will be grouped according to their age as follows: Group 1 includes subjects ≥12y to&#xD;
      &lt;18y, Group 2 includes subjects ≥6y to &lt;12y, Group 3 includes subjects ≥2y to &lt;6y, and Group&#xD;
      4 includes subjects ≥28days to &lt;2y.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">October 17, 2024</completion_date>
  <primary_completion_date type="Actual">February 25, 2022</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 (ORR)</measure>
    <time_frame>Cycle 7 Day 1 (Day 168)</time_frame>
    <description>ORR is defined as the proportion of subjects demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response. The response is assessed per NIH consensus criteria (Lee et al 2015) and scoring of response will be relative to the organ stage at the start of study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ruxolitinib concentrations by timepoint</measure>
    <time_frame>Cycle 7 Day 1 (from baseline to Day 168)</time_frame>
    <description>PK of ruxolitinib in treatment-naïve cGvHD and SR-cGvHD pediatric subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>From baseline up to end of study treatment, up to 36 months</time_frame>
    <description>Time from first response until cGvHD progression, death, or the date of addition of systemic therapies for cGvHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Cycle 4 Day 1 (Day 84)</time_frame>
    <description>Proportion of subjects who achieve OR (CR+PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR)</measure>
    <time_frame>Until Cycle 7 Day 1 (Day 168) or the start of additional systemic therapy for cGvHD</time_frame>
    <description>Proportion of subjects who achieved OR (CR+PR) at any time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure free survival (FFS)</measure>
    <time_frame>From baseline up to 35 days after end of study treatment, up to 37 months</time_frame>
    <description>Composite time to event endpoint incorporating the following FFS events: i) relapse or recurrence of underlying disease or death due to underlying disease, ii) non-relapse mortality, or iii) addition or initiation of another systemic therapy for cGvHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of malignancy relapse/recurrence (MR)</measure>
    <time_frame>From baseline up to 35 days after end of study treatment, up to 37 months</time_frame>
    <description>Defined as the time from date of treatment assignment to hematologic malignancy relapse/recurrence. Calculated for subjects with underlying hematologic malignant disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-relapse mortality (NRM)</measure>
    <time_frame>From baseline up to 35 days after end of study treatment, up to 37 months</time_frame>
    <description>Defined as the time from date of treatment assignment to date of death not preceded by underlying disease relapse/recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From baseline up to 35 days after end of study treatment, up to 37 months</time_frame>
    <description>Defined as the time from the date of treatment assignment to the date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with ≥50% reduction from baseline in daily corticosteroid dose</measure>
    <time_frame>Cycle 7 Day 1 (Day 168)</time_frame>
    <description>Reduction of at least ≥50% in daily corticosteroid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with a reduction to a low dose corticosteriod</measure>
    <time_frame>Cycle 7 Day 1 (Day 168)</time_frame>
    <description>Reduction in daily corticosteroid dose to ≤0.2mg/kg/day methylprednisolone(or equivalent dose of ≤0.25mg/kg/day prednisone or prednisolone)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft failure</measure>
    <time_frame>From baseline up to 35 days after end of study treatment, up to 37 months</time_frame>
    <description>Assess using donor cell chimerism, defined as initial whole blood or marrow donor chimerism for those who had ≥ 5% donor cell chimerism at baseline. If donor cell chimerism declines to &lt;5% on subsequent measurements, the graft failure is declared</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Graft vs Host Disease</condition>
  <arm_group>
    <arm_group_label>INC424 (ruxolitinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who will be administered 5mg ruxolitinib tablet or ruxolitinib oral pediatric formulation twice a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INC424</intervention_name>
    <description>Ruxolitinib is taken orally either as 5mg tablets or as pediatric formulation (dosage based on age group)</description>
    <arm_group_label>INC424 (ruxolitinib)</arm_group_label>
    <other_name>Ruxolitinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects age ≥28 days and &lt;18 years at the time of informed consent.&#xD;
&#xD;
          -  Subjects who have undergone alloSCT from any donor source (matched unrelated donor,&#xD;
             sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord&#xD;
             blood. Recipients of myeloablative or reduced intensity conditioning are eligible.&#xD;
&#xD;
          -  Subjects with diagnosed moderate to severe cGvHD according to NIH 2014 Consensus&#xD;
             Criteria (Section 16.2) prior to Cycle 1 Day 1. Other possible diagnoses for clinical&#xD;
             symptoms supporting cGvHD diagnoses must be excluded (e.g., infection, drug side&#xD;
             effects, malignancy). Subjects must be either:&#xD;
&#xD;
               -  Treatment-naive cGvHD subjects that have not received any prior systemic&#xD;
                  treatment for cGvHD except for a maximum 72h of prior systemic corticosteroid&#xD;
                  therapy of methylprednisolone or equivalent after the onset of chronic GvHD.&#xD;
                  Subjects are allowed to have received prior systemic treatment for cGvHD&#xD;
                  prophylaxis (as long as the prophylaxis was started prior to the diagnosis of&#xD;
                  cGvHD).&#xD;
&#xD;
        OR o Steroid-refractory moderate to severe cGvHD as per institutional criteria, or per&#xD;
        physician decision in case institutional criteria are not available, and still receiving&#xD;
        systemic corticosteroids for the treatment of cGvHD for a duration of &lt;18 months prior to&#xD;
        Cycle 1 Day 1. In case the corticosteroids were previously interrupted due to response, the&#xD;
        duration of &lt; 18 months applies to the last period of corticosteroid use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  SR-cGvHD subjects with a prior cGvHD treatment with a JAK1- or a JAK2- or a&#xD;
             JAK1/2-inhibitor, except when the subject achieved complete or partial response and&#xD;
             has been off JAK inhibitor treatment for at least 4 weeks prior to Cycle Day 1 or up&#xD;
             to 5 times the half-life of the prior JAK inhibitor, whichever is longer.&#xD;
&#xD;
             * Subjects who initiated systemic calcineurin inhibitors (CNI; cyclosporine or&#xD;
             tacrolimus) within 3 weeks prior to start of ruxolitinib on Cycle 1 Day 1. Note:&#xD;
             systemic CNI are allowed when initiated &gt; 3 weeks from start of ruxolitinib.&#xD;
&#xD;
          -  Failed prior alloSCT within the past 6 months&#xD;
&#xD;
          -  Significant respiratory disease including subjects who are on mechanical ventilation&#xD;
             or who have a resting oxygen saturation &lt; 90% by pulse-oximetry on room-air.&#xD;
&#xD;
          -  Impairment of gastrointestinal (GI) function (unrelated to GvHD) or GI disease&#xD;
             (unrelated to GvHD) that may significantly alter the absorption of oral ruxolitinib&#xD;
             (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption&#xD;
             syndrome or small bowel resection),&#xD;
&#xD;
          -  Cholestatic disorders, or unresolved sinusoidal obstructive syndrome/veno-occlusive&#xD;
             disease of the liver (defined as persistent bilirubin abnormalities not attributable&#xD;
             to cGvHD and ongoing organ dysfunction)&#xD;
&#xD;
          -  Presence of clinically active uncontrolled infection including significant bacterial,&#xD;
             fungal, viral or parasitic infection requiring treatment.&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on&#xD;
             assessment done by Investigator or delegate.&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to any of the study medications,&#xD;
             excipients, or similar compounds.&#xD;
&#xD;
          -  History of bone disorders such as osteogenesis imperfecta, rickets, renal&#xD;
             osteodystrophy, osteomyelitis, osteopenia, fibrous dysplasia, osteomalacia etc. prior&#xD;
             to the underlying diagnosis which resulted in the alloSCT.&#xD;
&#xD;
          -  History of endocrine or kidney related growth retardation prior to the underlying&#xD;
             diagnosis which resulted in the alloSCT.&#xD;
&#xD;
          -  Evidence of clinically active tuberculosis (clinical diagnosis per local practice)&#xD;
&#xD;
          -  Any corticosteroid therapy for indications other than cGvHD at doses &gt; 1&#xD;
             mg/kg/daymethylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7&#xD;
             days of the screening visit.&#xD;
&#xD;
          -  History of progressive multifocal leuko-encephalopathy (PML).&#xD;
&#xD;
          -  Presence of severely impaired renal function&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04039 001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tamil Nadu</city>
        <state>Chennai</state>
        <zip>600035</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560099</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Delhi</city>
        <zip>110 085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>466 8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saitama</city>
        <zip>330 8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sain Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bratislava</city>
        <zip>833 40</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Zuerich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Adana</city>
        <zip>1330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Antalya</city>
        <zip>07000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Antalya</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Lithuania</country>
    <country>Slovenia</country>
  </removed_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>INC424</keyword>
  <keyword>pediatric</keyword>
  <keyword>Chronic Graft versus Host Disease</keyword>
  <keyword>moderate and severe chronic graft vs. host disease</keyword>
  <keyword>allogeneic stem cell transplant</keyword>
  <keyword>ruxolitinib</keyword>
  <keyword>corticosteroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.</ipd_description>
  </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/NCT03774082
org study id: CINC424G12201
secondary id: 2018-003296-35
nct id: NCT03774082
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This open-label, single-arm, Phase II multi-center study will enroll approximately 42
      subjects and investigate the activity, pharmacokinetics and safety of ruxolitinib added to
      the subject's immunosuppressive regimen among infants, children, and adolescents aged ≥28
      days to <18 years old with either moderate to severe treatment-naive cGvHD or SR-cGvHD.
      Subjects will be grouped according to their age as follows: Group 1 includes subjects ≥12y to
      <18y, Group 2 includes subjects ≥6y to <12y, Group 3 includes subjects ≥2y to <6y, and Group
      4 includes subjects ≥28days to <2y.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: Cycle 7 Day 1 (Day 168)
description: ORR is defined as the proportion of subjects demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response. The response is assessed per NIH consensus criteria (Lee et al 2015) and scoring of response will be relative to the organ stage at the start of study treatment.
measure: Ruxolitinib concentrations by timepoint
time frame: Cycle 7 Day 1 (from baseline to Day 168)
description: PK of ruxolitinib in treatment-naïve cGvHD and SR-cGvHD pediatric subjects
measure: Duration of response (DOR)
time frame: From baseline up to end of study treatment, up to 36 months
description: Time from first response until cGvHD progression, death, or the date of addition of systemic therapies for cGvHD
measure: Overall Response Rate (ORR)
time frame: Cycle 4 Day 1 (Day 84)
description: Proportion of subjects who achieve OR (CR+PR)
measure: Best overall response (BOR)
time frame: Until Cycle 7 Day 1 (Day 168) or the start of additional systemic therapy for cGvHD
description: Proportion of subjects who achieved OR (CR+PR) at any time point
measure: Failure free survival (FFS)
time frame: From baseline up to 35 days after end of study treatment, up to 37 months
description: Composite time to event endpoint incorporating the following FFS events: i) relapse or recurrence of underlying disease or death due to underlying disease, ii) non-relapse mortality, or iii) addition or initiation of another systemic therapy for cGvHD
measure: Cumulative incidence of malignancy relapse/recurrence (MR)
time frame: From baseline up to 35 days after end of study treatment, up to 37 months
description: Defined as the time from date of treatment assignment to hematologic malignancy relapse/recurrence. Calculated for subjects with underlying hematologic malignant disease
measure: Non-relapse mortality (NRM)
time frame: From baseline up to 35 days after end of study treatment, up to 37 months
description: Defined as the time from date of treatment assignment to date of death not preceded by underlying disease relapse/recurrence
measure: Overall survival (OS)
time frame: From baseline up to 35 days after end of study treatment, up to 37 months
description: Defined as the time from the date of treatment assignment to the date of death due to any cause
measure: Percentage of participants with ≥50% reduction from baseline in daily corticosteroid dose
time frame: Cycle 7 Day 1 (Day 168)
description: Reduction of at least ≥50% in daily corticosteroid use
measure: Percentage of participants with a reduction to a low dose corticosteriod
time frame: Cycle 7 Day 1 (Day 168)
description: Reduction in daily corticosteroid dose to ≤0.2mg/kg/day methylprednisolone(or equivalent dose of ≤0.25mg/kg/day prednisone or prednisolone)
measure: Graft failure
time frame: From baseline up to 35 days after end of study treatment, up to 37 months
description: Assess using donor cell chimerism, defined as initial whole blood or marrow donor chimerism for those who had ≥ 5% donor cell chimerism at baseline. If donor cell chimerism declines to <5% on subsequent measurements, the graft failure is declared
arm group label: INC424 (ruxolitinib)
arm group type: Experimental
description: Subjects who will be administered 5mg ruxolitinib tablet or ruxolitinib oral pediatric formulation twice a day.
intervention type: Drug
intervention name: INC424
description: Ruxolitinib is taken orally either as 5mg tablets or as pediatric formulation (dosage based on age group)
arm group label: INC424 (ruxolitinib)
other name: Ruxolitinib
criteria: 
gender: All
minimum age: 28 Days
maximum age: 18 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Canada
country: Czechia
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Russian Federation
country: Slovakia
country: Spain
country: Switzerland
country: Taiwan
country: Thailand
country: Turkey
country: Argentina
country: Lithuania
country: Slovenia
responsible party type: Sponsor
mesh term: Graft vs Host Disease
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.