<?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>IRCT20140818018842N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-22</date_registration>
      <primary_sponsor>Hematology, Oncology &amp; Stem Cell Transplantation Research Center, Tehran University of Medical Sci.</primary_sponsor>
      <public_title>Effect of arsenic trioxide in induction of complete remission of acute myeloid leukemia(non m3)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of arsenic trioxide adding to standard regimen 7-3 in acute myeloid leukemia patients: a Randomized single blind clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32021</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into 2 study groups by balanced block randomization. The list of randomized patients is made by a person not involved in the study and then the participants are randomly assigned into treatment groups, Blinding description: The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups control(standard chemotherapy receiver) and intervention group(arsenic plus standard chemotherapy receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only at the end of the study, the results are reported by a person not involved in the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute myeloid leukemia ( non m3).</hc_freetext>
      <i_freetext>Intervention 1: intervention group: received Standard chemotherapy regimen consists of 3 days of an anthracycline e.g daunorubicin at 60 mg/m2  and 7 days of cytarabine (100 mg/m2 continuous infusion) plus arsenic at 0.15 mg/kg for 21 days. Intervention 2: control group: received standard chemotherapy regimen consist of 7 days cytarabin at 100mg/m2 and 3 days daunorubicin at 60 mg/m2.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Manouchehri Ardekani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Kaargar shomali Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713131</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>manouchehrireza9@gmail.com</email>
        <affiliation>Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Vaezi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Kaargar Shomali Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713131</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>ctu@tums.ac.ir</email>
        <affiliation>Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a newly diagnosis of AML according to the criteria of the WHO 2016 revision
Age 15-59years
Diagnosis of primary AML  other than acute promyeloctic leukemia (AML M3),
Adequate liver (serum bilirubin level &lt; 2upper normal limit) and renal function test (serum creatinine  &lt;1.5upper normal limit or creatinine clearance &gt;60)
Normal cardiac function
Females of childbearing age must have a negative serum pregnancy test
ECOG &lt;=2
Signed consent</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Newly diagnosed patients older than age 60.
CML in blastic crisis
Patients with cardiopathies including recurrent supraventricular arrhythmia and any type of sustained ventricular arrhythmia or conduction block (A-V block grade II or III)
Pregnant or breastfeeding women
History of preexisting neurological disorders ( seizure disorders)
Patients with active second malignancy, excluding adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C92.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myeloblastic leukemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: received Standard chemotherapy regimen consists of 3 days of an anthracycline e.g daunorubicin at 60 mg/m2  and 7 days of cytarabine (100 mg/m2 continuous infusion) plus arsenic at 0.15 mg/kg for 21 days.</i_keyword>
      <i_keyword>control group: received standard chemotherapy regimen consist of 7 days cytarabin at 100mg/m2 and 3 days daunorubicin at 60 mg/m2.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of effect of adding arsenic to standard chemotherapy on induction of complete remission of acute myeloid leukemia except m3. Timepoint: 14 and 28 days after start of chemotherapy we performed bone marrow examination to evaluate  remission rate. Method of measurement: Bone marrow microscopic evaluation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Overall survival. Timepoint: 3 years  after  treatment completion. Method of measurement: follow up.</sec_outcome>
      <sec_outcome>Disease free survival. Timepoint: 3 years after treatment completion (1 - 2 months interval). Method of measurement: follow up.</sec_outcome>
      <sec_outcome>Arsenic Safty. Timepoint: within first 28 days. Method of measurement: Patient monitoring and Electrocardiography monitoring and laboratory tests.</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>Hematology, Oncology &amp; Stem Cell Transplantation Research Center, Tehran University of Medical Sci.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-26</approval_date>
        <contact_name>Ethics Committee of Tehran University Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran town. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
