<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/NCT03260101</url>
  </required_header>
  <id_info>
    <org_study_id>ApoGraft01 FU</org_study_id>
    <nct_id>NCT03260101</nct_id>
  </id_info>
  <brief_title>Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study</brief_title>
  <official_title>A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cellect Biotechnology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cellect Biotechnology</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in&#xD;
      study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to&#xD;
      participate in this follow-up study.&#xD;
&#xD;
      Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up&#xD;
      study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post&#xD;
      transplantation, and will undergo the following evaluations: acute and chronic graft versus&#xD;
      host disease (GvHD) assessments, survival status (overall, relapse-free), disease status&#xD;
      (disease relapse/recurrence), physical examination, safety laboratory and concomitant&#xD;
      medication use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence, grade and stage of acute GvHD and chronic GvHD</measure>
    <time_frame>18 months</time_frame>
    <description>GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-relapse-related mortality</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with disease relapse/recurrence</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with relapse free and overall survival</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Acute Myelogenous Leukemia (AML)</condition>
  <condition>Acute Lymphoblastic Leukemia (ALL)</condition>
  <condition>Non Hodgkin Lymphoma (NHL)</condition>
  <condition>Hodgkin Lymphoma, Adult</condition>
  <arm_group>
    <arm_group_label>one group, ApoGraft Follow up Study</arm_group_label>
    <description>Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non intervational</intervention_name>
    <description>Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)</description>
    <arm_group_label>one group, ApoGraft Follow up Study</arm_group_label>
    <other_name>ApoGraft follow up</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this&#xD;
        follow-up study. Subjects must have had one of the Hemato-Oncology Diseases to enroll into&#xD;
        ApoGraft-01:&#xD;
&#xD;
          -  Acute myelogenous leukemia (AML) &amp; Acute lymphoblastic leukemia (ALL)&#xD;
&#xD;
          -  Non-Hodgkin's lymphoma (NHL)&#xD;
&#xD;
          -  Hodgkin's lymphoma (HL)&#xD;
&#xD;
          -  Intermediate, High or Very High risk Myelodysplastic syndrome (MDS)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who completed study ApoGraft-01 through 180 days (6 months)&#xD;
             post-transplantation&#xD;
&#xD;
          2. Ability to comply with the requirements of the study.&#xD;
&#xD;
          3. Signed written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Shai Yarkoni, MD</last_name>
    <phone>972-9-974-1444</phone>
    <email>shai@cellect.co</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsila Zuckerman, MD</last_name>
      <phone>+97247773248</phone>
      <email>t_zuckerman@rambam.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>November 24, 2019</last_update_submitted>
  <last_update_submitted_qc>November 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</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>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_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/NCT03260101
org study id: ApoGraft01 FU
nct id: NCT03260101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in
      study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to
      participate in this follow-up study.

      Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up
      study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post
      transplantation, and will undergo the following evaluations: acute and chronic graft versus
      host disease (GvHD) assessments, survival status (overall, relapse-free), disease status
      (disease relapse/recurrence), physical examination, safety laboratory and concomitant
      medication use.
observational model: Other
time perspective: Prospective
measure: Incidence, grade and stage of acute GvHD and chronic GvHD
time frame: 18 months
description: GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.
measure: Non-relapse-related mortality
time frame: 18 months
measure: Proportion of subjects with disease relapse/recurrence
time frame: 18 months
measure: Proportion of subjects with relapse free and overall survival
time frame: 18 months
arm group label: one group, ApoGraft Follow up Study
description: Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01
intervention type: Other
intervention name: non intervational
description: Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)
arm group label: one group, ApoGraft Follow up Study
other name: ApoGraft follow up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Shai Yarkoni, MD
phone: 972-9-974-1444
email: shai@cellect.co
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Lymphoma, Non-Hodgkin
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Hodgkin Disease
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No