<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20140818018842N51</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Does Eltrombopag Improve Blood Cell Recovery in Leukemia Patients After Transplant?</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Prophylactic Oral Eltrombopag for Promoting Platelet and Neutrophil Engraftment After Haploidentical Hematopoietic Stem Cell Transplantation in Patients with acute lymphoblastic leukemia: A Phase II Non Randomized-controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/82982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute lymphoblastic leukemia [ALL].</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patient with acute leukemia and recipient of haploidentical transplant  will receive oral Eltrombopag, which is a thrombopoietin receptor agonist and will be used to promote post- allogenic-hematopoietic-stem-cell-transplantation engraftment, at a daily dose of 150–300 mg starting from fifth day after transplantation and continuing daily until engraftment. Each patient will receive Eltrombopag for a minimum of 10 days, regardless of whether engraftment occurs before day 10 of Eltrombopag therapy. Patients must receive at least 10 consecutive days of Eltrombopag in order to be included in the final analysis. As a safety rule, if the patient’s platelet count reaches or exceeds 500,000 per μL after 10 days,  at any point during treatment, Eltrombopag must be discontinued. The eltrombopag used in this study will be purchased from Nano Darou Pharmaceutical Company. Intervention 2: Historical control patients will include patients with acute leukemia who received a haploidentical transplant and did not receive any medication to promote engraftment.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Institute for Oncology, Hematology and Cell Therapy, Shariati Hospital, North Kargar Street, Jalal Al-Ahmad Intersection, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>tah.rostami94@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Institute for Oncology, Hematology and Cell Therapy, Shariati Hospital, North Kargar Street, Jalal Al-Ahmad Intersection, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>tah.rostami94@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of acute lymphocytic leukemia
Medical indication of Haploidentical Hematopoietic Stem Cell Transplantation
The patient must be in Complete Remission before the transplant</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with abnormal liver function tests such as alanine aminotransferase greater equal than 2.5 times the upper limit of normal or bilirubin greater than1 mg/dL will not enter the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukemia [ALL]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patient with acute leukemia and recipient of haploidentical transplant  will receive oral Eltrombopag, which is a thrombopoietin receptor agonist and will be used to promote post- allogenic-hematopoietic-stem-cell-transplantation engraftment, at a daily dose of 150–300 mg starting from fifth day after transplantation and continuing daily until engraftment. Each patient will receive Eltrombopag for a minimum of 10 days, regardless of whether engraftment occurs before day 10 of Eltrombopag therapy. Patients must receive at least 10 consecutive days of Eltrombopag in order to be included in the final analysis. As a safety rule, if the patient’s platelet count reaches or exceeds 500,000 per μL after 10 days,  at any point during treatment, Eltrombopag must be discontinued. The eltrombopag used in this study will be purchased from Nano Darou Pharmaceutical Company.</i_keyword>
      <i_keyword>Historical control patients will include patients with acute leukemia who received a haploidentical transplant and did not receive any medication to promote engraftment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Platelet engraftment (when the patient is independent of platelet transfusion for at least 7 days with a platelet count &gt;20 × 10⁹/L). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.</prim_outcome>
      <prim_outcome>Neutrophil engraftment (when the absolute neutrophil count consistently exceeds 0.5 × (10)9/L for 3 days in a row without a growth factor support.). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.</prim_outcome>
      <prim_outcome>The occurrence of Graft versus Host disease according to the MAGIC criteria. Timepoint: Daily assessments , from 5 days before the start of the intervention (from the day of transplantation) and until 3 months after the intervention. Method of measurement: In accordance with the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.</prim_outcome>
      <prim_outcome>Overall survival. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Survival data will be collected  using a checklist that includes survival status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups.</prim_outcome>
      <prim_outcome>Relapse. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Relapse data will be collected  using a checklist that includes relapse status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups according to patients clinical records.</prim_outcome>
      <prim_outcome>Progression Free survival. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Survival and relapse data will be collected  using a checklist that includes survival and relapse status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups according to patients clinical records.</prim_outcome>
      <prim_outcome>Cytomegalovirus (CMV) reactivation. Timepoint: Weekly assessments , from 5 days before the start of the intervention (from the day of transplantation) and until 3 months after the intervention. Method of measurement: Polymerase chain reaction (PCR) lab test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-02</approval_date>
        <contact_name>Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran</contact_name>
        <contact_address>Research Institute for Oncology, Hematology and Cell Therapy, Shariati Hospital, North Kargar Street, Jalal Al-Ahmad Intersection, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
