<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/NCT03755414</url>
  </required_header>
  <id_info>
    <org_study_id>201903114</org_study_id>
    <nct_id>NCT03755414</nct_id>
  </id_info>
  <brief_title>Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation</brief_title>
  <official_title>A Single-Arm, Open-Label, Pilot Study and Expansion Study of JAK Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Society of Hematology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial, the investigators will begin to explore the possibility that, as in mice,&#xD;
      janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell&#xD;
      transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release&#xD;
      syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The&#xD;
      purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic&#xD;
      cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 4, 2019</start_date>
  <completion_date type="Anticipated">May 13, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 22, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of graft failure (pilot study only)</measure>
    <time_frame>35 days post haplo-HCT</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative incidence of grades III-IV acute GVHD</measure>
    <time_frame>Day 100</time_frame>
    <description>-Incidence of acute grade III-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who experience cytokine release syndrome (CRS)</measure>
    <time_frame>Through Day 8 (approximately 1 week post transplant)</time_frame>
    <description>The number of participants who experience CRS will be summarized by count of participants who experience Grade 1, 2, 3, 4, &amp; 5 CRS.&#xD;
Grade 1: symptoms not life threatening &amp; require symptomatic treatment alone, includes fever, nausea, fatigue, malaise&#xD;
Grade 2: symptoms require/respond to limited intervention - oxygen (O2) &lt;40%, &lt;=3 liters (L) nasal cannula or hypotension responsive to fluids or low dose of 1 vasopressor or grade 2 renal or hepatic toxicity&#xD;
Grade 3: symptoms require/respond to aggressive intervention - O2 &gt;=40%, &gt;3L nasal cannula or hypotension requiring high dose or multiple vasopressors or grade 3 renal toxicity or grade 4 transaminitis, new onset altered mental status, new cardiomyopathy without wall motion abnormality&#xD;
Grade 4: life-threatening symptoms - requirement for ventilator support or grade 4 rental toxicity (excluding transaminitis)&#xD;
Grade 5: death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment related mortality</measure>
    <time_frame>Day 180</time_frame>
    <description>-Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of grades II-IV acute GVHD (expansion phase)</measure>
    <time_frame>Day 100</time_frame>
    <description>-Incidence of acute grade II-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Acute Myelogenous Leukemia</condition>
  <condition>Acute Lymphocytic Leukemia</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <condition>Non-Hodgkin Lymphoma</condition>
  <condition>Hodgkin Disease</condition>
  <arm_group>
    <arm_group_label>Pilot Study: Itacitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy&#xD;
Stem cell transplantation on Day 0&#xD;
Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently&#xD;
To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Phase: Itacitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy&#xD;
Stem cell transplantation on Day 0&#xD;
Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently&#xD;
To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stem cell transplantation</intervention_name>
    <description>Standard of care</description>
    <arm_group_label>Expansion Phase: Itacitinib</arm_group_label>
    <arm_group_label>Pilot Study: Itacitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itacitinib</intervention_name>
    <description>Itacitinib may be taken without regard to food.</description>
    <arm_group_label>Expansion Phase: Itacitinib</arm_group_label>
    <arm_group_label>Pilot Study: Itacitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)</intervention_name>
    <description>Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)&#xD;
Screening, day 14, day 28, day 42, day 74, day 100, day 180, taper period, and follow-up period (expansion study)</description>
    <arm_group_label>Expansion Phase: Itacitinib</arm_group_label>
    <arm_group_label>Pilot Study: Itacitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human Activity Profile</intervention_name>
    <description>Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)&#xD;
Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)</description>
    <arm_group_label>Expansion Phase: Itacitinib</arm_group_label>
    <arm_group_label>Pilot Study: Itacitinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet the following criteria within 30 days prior to Day 0 unless otherwise&#xD;
        noted.&#xD;
&#xD;
          -  Diagnosis of a hematological malignancy listed below:&#xD;
&#xD;
               -  Acute myelogenous leukemia (AML) in complete morphological remission (based on&#xD;
                  International Working Group (IWG) Criteria)&#xD;
&#xD;
               -  Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD&#xD;
                  negative, based on IWG Criteria)&#xD;
&#xD;
               -  Myelodysplastic syndrome with ≤ 5% blasts in bone marrow.&#xD;
&#xD;
               -  Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete&#xD;
                  or partial remission.&#xD;
&#xD;
          -  Planned treatment is myeloablative or reduced intensity conditioning followed by T&#xD;
             Cell-replete peripheral blood haploidentical donor transplantation&#xD;
&#xD;
          -  Available human leukocyte antigen (HLA)-haploidentical donor who meets the following&#xD;
             criteria:&#xD;
&#xD;
               -  Blood-related family member, including (but not limited to) sibling, offspring,&#xD;
                  cousin, nephew, or parent. Younger donors should be prioritized.&#xD;
&#xD;
               -  At least 18 years of age&#xD;
&#xD;
               -  HLA-haploidentical donor/recipient match by at least low-resolution typing per&#xD;
                  institutional standards.&#xD;
&#xD;
               -  In the investigator's opinion, is in general good health, and medically able to&#xD;
                  tolerate leukapheresis required for harvesting hematopoietic stem cells (HSC).&#xD;
&#xD;
               -  No active hepatitis.&#xD;
&#xD;
               -  Negative for human T-cell lymphotrophic virus (HTLV) and human immunodeficiency&#xD;
                  virus (HIV).&#xD;
&#xD;
               -  Not pregnant.&#xD;
&#xD;
               -  Safety Lead-In Phase: For the first three patients, the donor must consent to a&#xD;
                  second product collection should it prove necessary.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          -  Adequate organ function as defined below:&#xD;
&#xD;
               -  Total bilirubin must be within normal range at baseline&#xD;
&#xD;
               -  Aspartate aminotransferase (AST)(SGOT) and alanine aminotransferase (ALT) (SGPT)&#xD;
                  ≤ 3.0 x institutional upper limit of normal (IULN).&#xD;
&#xD;
               -  Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 45 mL/min/1.73 m^2 by&#xD;
                  Cockcroft-Gault Formula.&#xD;
&#xD;
               -  Oxygen saturation ≥ 90% on room air.&#xD;
&#xD;
               -  Left ventricular ejection fraction (LVEF) ≥ 40%.&#xD;
&#xD;
               -  Forced expiratory volume (FEV1) and forced vital capacity (FVC) ≥ 40% predicted,&#xD;
                  diffusing capacity of the lung for carbon monoxide (DLCOc) ≥ 40% predicted. If&#xD;
                  DLCO is &lt; 40%, patients will still be considered eligible if deemed safe after a&#xD;
                  pulmonary evaluation.&#xD;
&#xD;
          -  At least 18 years of age at the time of study registration&#xD;
&#xD;
          -  Able to understand and willing to sign an Institutional Review Board (IRB) approved&#xD;
             written informed consent document (or that of legally authorized representative, if&#xD;
             applicable).&#xD;
&#xD;
          -  Must be able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil, and&#xD;
             cyclophosphamide&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not have undergone a prior allogeneic donor (related, unrelated, or cord)&#xD;
             transplant. Prior autologous transplant is not exclusionary.&#xD;
&#xD;
          -  Presence of donor-specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of&#xD;
             ≥2000 as assessed by the single antigen bead assay.&#xD;
&#xD;
          -  Known HIV or active hepatitis B or C infection.&#xD;
&#xD;
          -  Known hypersensitivity to one or more of the study agents, including Ruxolitinib and&#xD;
             Itacitinib.&#xD;
&#xD;
          -  Must not have myelofibrosis (unless they are enrolled Amendment #5 or later) or other&#xD;
             disease known to prolong neutrophil engraftment to &gt; 35 days after transplant.&#xD;
&#xD;
          -  Must not receive antithymocyte globulin as part of pre-transplant conditioning&#xD;
             regimens.&#xD;
&#xD;
          -  Currently receiving or has received any investigational drugs within the 14 days prior&#xD;
             to the first dose of study drug (Day -3).&#xD;
&#xD;
          -  Pregnant and/or breastfeeding.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, autoimmune disease, symptomatic congestive heart failure, unstable angina&#xD;
             pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements.&#xD;
&#xD;
          -  Immunosuppressive doses of steroids. Subjects with steroids for adrenal insufficiency&#xD;
             will not be excluded.&#xD;
&#xD;
        Additional Inclusion Criteria Under Amendment 5&#xD;
&#xD;
          -  Five subjects with myelofibrosis will be enrolled in the expansion phase.&#xD;
&#xD;
          -  Three patients whose donors fail to collect the target number of CD34+ cells and the&#xD;
             treating physician choses to move forward with the haplo-HCT will be enrolled in the&#xD;
             expansion phase.&#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>Ramzi Abboud, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ramzi Abboud, M.D.</last_name>
    <phone>314-454-8304</phone>
    <email>rabboud@wustl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramzi Abboud, M.D.</last_name>
      <phone>314-454-8304</phone>
      <email>rabboud@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Ramzi Abboud, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark A Schroeder, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John F DiPersio, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Westervelt, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camille Abboud, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amanda Cashen, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Keith Stockerl-Goldstein, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ravi Vij, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Geoffrey Uy, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mathew Walter, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Todd Fehniger, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Armin Ghobadi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meagan Jacoby, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Iskra Pusic, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lukas Wartman, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Welch, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tanya Wildes, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Terrence Wong, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Francesca Ferraro, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Cytokine Release Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The study protocol will also be made available. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;), for the purpose of achieving their approved aims. Patient who opt out of data sharing will not be included.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning 9 months and ending 36 months following article publication</ipd_time_frame>
  </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/NCT03755414
org study id: 201903114
nct id: NCT03755414
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
In this trial, the investigators will begin to explore the possibility that, as in mice,
      janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell
      transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release
      syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The
      purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic
      cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative incidence of graft failure (pilot study only)
time frame: 35 days post haplo-HCT
measure: Cumulative incidence of grades III-IV acute GVHD
time frame: Day 100
description: -Incidence of acute grade III-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
measure: Number of participants who experience cytokine release syndrome (CRS)
time frame: Through Day 8 (approximately 1 week post transplant)
description: The number of participants who experience CRS will be summarized by count of participants who experience Grade 1, 2, 3, 4, & 5 CRS.
Grade 1: symptoms not life threatening & require symptomatic treatment alone, includes fever, nausea, fatigue, malaise
Grade 2: symptoms require/respond to limited intervention - oxygen (O2) <40%, <=3 liters (L) nasal cannula or hypotension responsive to fluids or low dose of 1 vasopressor or grade 2 renal or hepatic toxicity
Grade 3: symptoms require/respond to aggressive intervention - O2 >=40%, >3L nasal cannula or hypotension requiring high dose or multiple vasopressors or grade 3 renal toxicity or grade 4 transaminitis, new onset altered mental status, new cardiomyopathy without wall motion abnormality
Grade 4: life-threatening symptoms - requirement for ventilator support or grade 4 rental toxicity (excluding transaminitis)
Grade 5: death
measure: Treatment related mortality
time frame: Day 180
description: -Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
measure: Cumulative incidence of grades II-IV acute GVHD (expansion phase)
time frame: Day 100
description: -Incidence of acute grade II-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
arm group label: Pilot Study: Itacitinib
arm group type: Experimental
description: Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy
Stem cell transplantation on Day 0
Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently
To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
arm group label: Expansion Phase: Itacitinib
arm group type: Experimental
description: Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy
Stem cell transplantation on Day 0
Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
intervention type: Procedure
intervention name: Stem cell transplantation
description: Standard of care
arm group label: Expansion Phase: Itacitinib
arm group label: Pilot Study: Itacitinib
intervention type: Drug
intervention name: Itacitinib
description: Itacitinib may be taken without regard to food.
arm group label: Expansion Phase: Itacitinib
arm group label: Pilot Study: Itacitinib
intervention type: Other
intervention name: Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
description: Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)
Screening, day 14, day 28, day 42, day 74, day 100, day 180, taper period, and follow-up period (expansion study)
arm group label: Expansion Phase: Itacitinib
arm group label: Pilot Study: Itacitinib
intervention type: Other
intervention name: Human Activity Profile
description: Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)
Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)
arm group label: Expansion Phase: Itacitinib
arm group label: Pilot Study: Itacitinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ramzi Abboud, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Ramzi Abboud, M.D.
phone: 314-454-8304
email: rabboud@wustl.edu
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status: Recruiting
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country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Hodgkin Disease
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Myelodysplastic Syndromes
mesh term: Graft vs Host Disease
mesh term: Syndrome
mesh term: Cytokine Release Syndrome
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The study protocol will also be made available. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary"), for the purpose of achieving their approved aims. Patient who opt out of data sharing will not be included.
ipd info type: Study Protocol
ipd time frame: Data will be available beginning 9 months and ending 36 months following article publication