<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/NCT03790332</url>
  </required_header>
  <id_info>
    <org_study_id>PCYC-1146-IM</org_study_id>
    <secondary_id>2017-004558-41</secondary_id>
    <nct_id>NCT03790332</nct_id>
  </id_info>
  <brief_title>Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)</brief_title>
  <official_title>Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmacyclics LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pharmacyclics LLC.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus&#xD;
      Host Disease (cGVHD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">January 4, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 4, 2026</primary_completion_date>
  <phase>Phase 1/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>Part A- PK (measured by AUC) will be reported descriptively</measure>
    <time_frame>Approximately 24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B- PK (measured by AUC) will be reported descriptively</measure>
    <time_frame>Approximately 7 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Approximately 7 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A- Number of patients with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A- Pharmacodynamic effects as measured by in vitro BTK occupancy will be reported descriptively</measure>
    <time_frame>Approximately 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A continuation cohort and Part B-Response rate at 24 weeks</measure>
    <time_frame>Approximately 6 months after last subject in enrolled</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A continuation cohort and Part B- Duration of response (DOR)</measure>
    <time_frame>Up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A continuation cohort and Part B-Overall survival (OS)</measure>
    <time_frame>Approximately 5 years after last subject enrolled</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A continuation cohort and Part B-Late Effects Surveillance</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth Parameter height in meters will be reported descriptively</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
    <description>Subjects will be monitored for growth and development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth Parameter weight in kilograms will be reported descriptively.</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
    <description>Subjects will be monitored for growth and development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Available immune reconstitution laboratory parameters will be reported descriptively</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
    <description>Subjects will be monitored for immune reconstitution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late effects (Adverse events suspected to be related to treatment) will be quantified and reported descriptively</measure>
    <time_frame>Up to 5 years post enrollment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Chronic Graft Versus Host Disease</condition>
  <arm_group>
    <arm_group_label>Phase 1/2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part A: Subjects ≥1 to &lt;12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED).&#xD;
Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED.&#xD;
Part B: Subjects ≥1 to &lt;12 years of age( upper age limit is &lt; 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibrutinib</intervention_name>
    <description>Ibrutinib capsule, tablet, or suspension administered orally once daily</description>
    <arm_group_label>Phase 1/2</arm_group_label>
    <other_name>IMBRUVICA®</other_name>
    <other_name>PCI-32765</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Eligibility:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of&#xD;
             systemic therapy&#xD;
&#xD;
          2. Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of&#xD;
             systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of&#xD;
             systemic immunosuppression&#xD;
&#xD;
          3. History of allogeneic stem cell transplantation&#xD;
&#xD;
          4. Age&#xD;
&#xD;
               -  Part A: ≥1 to &lt;12 years of age at the time of enrollment&#xD;
&#xD;
               -  Part B: ≥1 to &lt;22 years of age at the time of enrollment&#xD;
&#xD;
          5. Karnofsky or Lansky (subjects &lt;16 years of age) performance status ≥60&#xD;
&#xD;
        Key Eligibility:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD&#xD;
&#xD;
          2. Received an investigational agent within 28 days before enrollment.&#xD;
&#xD;
          3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment&#xD;
&#xD;
          4. Progressive underlying malignant disease or active post-transplant lymphoproliferative&#xD;
             disease&#xD;
&#xD;
          5. Any uncontrolled infection or active infection requiring ongoing systemic treatment&#xD;
&#xD;
          6. Known bleeding disorders&#xD;
&#xD;
          7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gauri Sunkersett</last_name>
    <role>Study Director</role>
    <affiliation>Pharmacyclics LLC.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Masonic Children's Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-2729</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center for Children. The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queensland Children's Hospital</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Children's Hospital</name>
      <address>
        <city>Randwick</city>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Anna Kinderspital</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>children's and Women's Health Centre of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Hopital Enfant Adolescent</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert-Debré Ap-Hp</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite-Universitaetsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Centre</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center in Israel</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Edmond and Lily Safra Children's Hospital</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O.C. Ematologia Oncoematologia Pediatrica</name>
      <address>
        <city>Pavia</city>
        <state>PV</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione MBBM-Clinica Pediatrica</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica</name>
      <address>
        <city>Roma</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Saint Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Maxima Center</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CS</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Educational Institution of Higher Professional Education &quot;LP.Pavlov First Saint Petersburg State Medical</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Nino Jesus</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Safari Day Care, Great Ormond Street Hospital</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cGVHD</keyword>
  <keyword>chronic graft versus host disease</keyword>
  <keyword>PCYC1146IM</keyword>
  <keyword>Pediatric</keyword>
  <keyword>GVHD</keyword>
  <keyword>chronic</keyword>
  <keyword>1146</keyword>
  <keyword>Pharmacyclics</keyword>
  <keyword>PCYC</keyword>
  <keyword>Imbruvica</keyword>
  <keyword>Ibrutinib</keyword>
  <keyword>Immunology</keyword>
  <keyword>graft versus host disease</keyword>
  <keyword>corticosteroids</keyword>
  <keyword>prednisone</keyword>
  <keyword>PCI32765</keyword>
  <keyword>PCYC1146</keyword>
  <keyword>refractory</keyword>
  <keyword>new onset graft versus host disease</keyword>
  <keyword>refractory graft versus host disease</keyword>
  <keyword>moderate cGVHD</keyword>
  <keyword>severe cGVHD</keyword>
  <keyword>moderate chronic graft versus host disease</keyword>
  <keyword>severe chronic graft versus host disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis Obliterans Syndrome</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_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/NCT03790332
org study id: PCYC-1146-IM
secondary id: 2017-004558-41
nct id: NCT03790332
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus
      Host Disease (cGVHD)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part A- PK (measured by AUC) will be reported descriptively
time frame: Approximately 24 months
measure: Part B- PK (measured by AUC) will be reported descriptively
time frame: Approximately 7 years
measure: Number of patients with adverse events as a measure of safety and tolerability
time frame: Approximately 7 years
measure: Part A- Number of patients with adverse events as a measure of safety and tolerability
time frame: Approximately 24 months
measure: Part A- Pharmacodynamic effects as measured by in vitro BTK occupancy will be reported descriptively
time frame: Approximately 24 months
measure: Part A continuation cohort and Part B-Response rate at 24 weeks
time frame: Approximately 6 months after last subject in enrolled
measure: Part A continuation cohort and Part B- Duration of response (DOR)
time frame: Up to 48 weeks
measure: Part A continuation cohort and Part B-Overall survival (OS)
time frame: Approximately 5 years after last subject enrolled
measure: Part A continuation cohort and Part B-Late Effects Surveillance
time frame: Up to 5 years post enrollment
measure: Growth Parameter height in meters will be reported descriptively
time frame: Up to 5 years post enrollment
description: Subjects will be monitored for growth and development
measure: Growth Parameter weight in kilograms will be reported descriptively.
time frame: Up to 5 years post enrollment
description: Subjects will be monitored for growth and development
measure: Available immune reconstitution laboratory parameters will be reported descriptively
time frame: Up to 5 years post enrollment
description: Subjects will be monitored for immune reconstitution
measure: Late effects (Adverse events suspected to be related to treatment) will be quantified and reported descriptively
time frame: Up to 5 years post enrollment
arm group label: Phase 1/2
arm group type: Experimental
description: Part A: Subjects ≥1 to <12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED).
Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED.
Part B: Subjects ≥1 to <12 years of age( upper age limit is < 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.
intervention type: Drug
intervention name: Ibrutinib
description: Ibrutinib capsule, tablet, or suspension administered orally once daily
arm group label: Phase 1/2
other name: IMBRUVICA®
other name: PCI-32765
criteria: 
gender: All
minimum age: 1 Year
maximum age: 21 Years
healthy volunteers: No
last name: Gauri Sunkersett
role: Study Director
affiliation: Pharmacyclics LLC.
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country: Australia
country: Austria
country: Canada
country: France
country: Germany
country: Israel
country: Italy
country: Korea, Republic of
country: Netherlands
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Bronchiolitis Obliterans Syndrome
mesh term: Graft vs Host Disease