<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/NCT01723657</url>
  </required_header>
  <id_info>
    <org_study_id>AML-03</org_study_id>
    <nct_id>NCT01723657</nct_id>
  </id_info>
  <brief_title>Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)</brief_title>
  <official_title>Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The AML-03 regimen investigates the addition of G-CSF priming to both induction and&#xD;
      consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines&#xD;
      risk-stratification based on biological characterization also the AML-03 trial incorporates&#xD;
      novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ &quot;in vivo&#xD;
      purging&quot; in autografts, extends unrelated volunteers donors for allotransplants in high-risk&#xD;
      patients, and introduces reduced intensity conditioning in patients with elder age (more than&#xD;
      50 years old).&#xD;
&#xD;
      The aims of these modifications are to analyse eficacy and toxicity of this induction and&#xD;
      consolidation therapy and to analyse the disease free survival in patients who achieved&#xD;
      complete response following a risk adjusted therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5),&#xD;
      intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide&#xD;
      (100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the&#xD;
      addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction&#xD;
      therapy is repeated if complete remission (CR) is not achieved after the first course of&#xD;
      treatment.&#xD;
&#xD;
      Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4 to&#xD;
      6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).&#xD;
&#xD;
      Risk-stratification according to cytogenetics, courses to CR and availability of an&#xD;
      HLA-identical sibling:&#xD;
&#xD;
        -  Patients in the favorable cytogenetics group [t(8;21), inv(16) or t(16;16)] and&#xD;
           Leukocyte index &lt;20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone&#xD;
           marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h, intravenous,&#xD;
           days 1, 3 and 5), but in case of LI&gt;20 at diagnosis the intention is to perform an&#xD;
           autologous peripheral blood stem cell (PBSC) transplantation.&#xD;
&#xD;
        -  Patients in intermediate risk group, with normal karyotype, a single course of induction&#xD;
           chemotherapy to achieve the CR, the absence of adverse molecular features (FLT3-ITD or&#xD;
           MLL-PTD) and low minimal residual disease levels after consolidation (MRD&lt;0,1%) receive&#xD;
           an autologous PBSC transplant, regardless of having an HLA-identical sibling.&#xD;
&#xD;
        -  The remaining patients defined as high-risk patients are treated with an allogeneic stem&#xD;
           cell transplantation. Depending on the age, if the patient has an HLA-identical sibling&#xD;
           donor, up to age of 50 years old it is performed with conventional conditioning therapy&#xD;
           and positive selection of CD34+, older patients receive a reduced intensity conditioning&#xD;
           regimen.&#xD;
&#xD;
        -  Very high risk patients without a sibling are allocated to unrelated donor (9-10/10).&#xD;
           Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received&#xD;
           Mylotarg™ as &quot;in vivo purging&quot; followed by an autologous PBSC transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2003</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>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>Complete remission rate (CRR)</measure>
    <time_frame>2 months.</time_frame>
    <description>Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease free survival (DFS).</measure>
    <time_frame>4 years.</time_frame>
    <description>Analyze the disease free suvival of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.&#xD;
Mortality in remission after chemotherapy and/or peripheral blood stem cell tranplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Toxicity in patients over 60 years old.</measure>
    <time_frame>4 years.</time_frame>
    <description>Toxicity of the induction and intensification treatment in patients with more than 60 years old, in terms of unexpected adverse drug reaction, morbidity and mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of minimal residual disease (MRD) by flow cytometry and/or molecular markers during and after treatment.</measure>
    <time_frame>4 years.</time_frame>
    <description>Study the immunophenotype characteristics and/or molecular markers at diagnosis, and during the different treatment phases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of post-remission treatment in patients with 60 or more years old.</measure>
    <time_frame>4 years.</time_frame>
    <description>Study the effect of post-remission treatments in patients with more than 60 years to evaluate the success of consolidation treatments.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">862</enrollment>
  <condition>Leukemia, Myelocytic, Acute</condition>
  <arm_group>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ara-C, G-CSF, Autologous peripheral blood stem cell transplantation, Allogeneic matched related or unrelated donor transplant, G-CSF Priming, CD34+ selection, Myeloablative or reduced intensity conditioning, Mylotarg purging before autologous PBSC transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ara-C</intervention_name>
    <description>Intermediate dose during induction phase to remission.&#xD;
High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autologous peripheral blood stem cell transplantation.</intervention_name>
    <description>In patients with favorable cytogenetics with a Leukocyte index above 20.&#xD;
Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Allogeneic matched related or unrelated donor transplant.</intervention_name>
    <description>-Patients without favorable/intermediate characteristics.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-CSF</intervention_name>
    <description>Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L.&#xD;
Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
    <other_name>Filgastrim.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CD34+ selection.</intervention_name>
    <description>-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mylotarg purging before autologous PBSC transplantation</intervention_name>
    <description>Patients without favorable/intermediate characteristics and without matched related donor.</description>
    <arm_group_label>Risk-adapted postremission treatment.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly diagnosed AML, classified using OMS criteria.&#xD;
&#xD;
          -  Patients with 70 years old or younger.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients previously treated for the AML with chemotherapy different from hidroxiurea.&#xD;
&#xD;
          -  Acute promyelocytic leukemia with t(15;17).&#xD;
&#xD;
          -  Cronic mieloid leukemia in blastic crisis.&#xD;
&#xD;
          -  Leukemias that appear after other myeloproliferative processes.&#xD;
&#xD;
          -  Leukemias that survive after myelodysplasic syndromes of more than 6 months of&#xD;
             evolution.&#xD;
&#xD;
          -  Presence of other neoplasic disease in activity.&#xD;
&#xD;
          -  Secondary AML which appears after cured malignant disease (for instance, Hodgking&#xD;
             disease), and those who are still exposed to alkilant agents or radiation.&#xD;
&#xD;
          -  Abnormal renal and hepatic functions with creatinin and/or bilirrubine 2 times higher&#xD;
             than the normal threshold, except when the alteration should be attributed to the&#xD;
             leukemia.&#xD;
&#xD;
          -  Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.&#xD;
&#xD;
          -  Patients with neurological or concomitant psychiatric disease.&#xD;
&#xD;
          -  Positivity by HIV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Sierra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salut Brunet, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet del Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital A Coruña</name>
      <address>
        <city>A Coruña</city>
        <state>Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Mallorca</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Son Dureta</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Mallorca</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Verge de la Cinta</name>
      <address>
        <city>Tortosa</city>
        <state>Tarragona</state>
        <zip>43517</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Teknon</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Universitari de Girona Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova</name>
      <address>
        <city>Lleida</city>
        <zip>25006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <zip>43007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mutua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <zip>08225</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Myeloid</keyword>
  <keyword>Acute</keyword>
  <keyword>Young</keyword>
  <keyword>CETLAM</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemtuzumab</mesh_term>
  </intervention_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/NCT01723657
org study id: AML-03
nct id: NCT01723657
lead sponsor: 
has dmc: No
The AML-03 regimen investigates the addition of G-CSF priming to both induction and
      consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines
      risk-stratification based on biological characterization also the AML-03 trial incorporates
      novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ "in vivo
      purging" in autografts, extends unrelated volunteers donors for allotransplants in high-risk
      patients, and introduces reduced intensity conditioning in patients with elder age (more than
      50 years old).

      The aims of these modifications are to analyse eficacy and toxicity of this induction and
      consolidation therapy and to analyse the disease free survival in patients who achieved
      complete response following a risk adjusted therapy.
Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5),
      intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide
      (100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the
      addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction
      therapy is repeated if complete remission (CR) is not achieved after the first course of
      treatment.

      Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4 to
      6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).

      Risk-stratification according to cytogenetics, courses to CR and availability of an
      HLA-identical sibling:

        -  Patients in the favorable cytogenetics group [t(8;21), inv(16) or t(16;16)] and
           Leukocyte index <20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone
           marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h, intravenous,
           days 1, 3 and 5), but in case of LI>20 at diagnosis the intention is to perform an
           autologous peripheral blood stem cell (PBSC) transplantation.

        -  Patients in intermediate risk group, with normal karyotype, a single course of induction
           chemotherapy to achieve the CR, the absence of adverse molecular features (FLT3-ITD or
           MLL-PTD) and low minimal residual disease levels after consolidation (MRD<0,1%) receive
           an autologous PBSC transplant, regardless of having an HLA-identical sibling.

        -  The remaining patients defined as high-risk patients are treated with an allogeneic stem
           cell transplantation. Depending on the age, if the patient has an HLA-identical sibling
           donor, up to age of 50 years old it is performed with conventional conditioning therapy
           and positive selection of CD34+, older patients receive a reduced intensity conditioning
           regimen.

        -  Very high risk patients without a sibling are allocated to unrelated donor (9-10/10).
           Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received
           Mylotarg™ as "in vivo purging" followed by an autologous PBSC transplantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete remission rate (CRR)
time frame: 2 months.
description: Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.
measure: Disease free survival (DFS).
time frame: 4 years.
description: Analyze the disease free suvival of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.
Mortality in remission after chemotherapy and/or peripheral blood stem cell tranplantation.
measure: Toxicity in patients over 60 years old.
time frame: 4 years.
description: Toxicity of the induction and intensification treatment in patients with more than 60 years old, in terms of unexpected adverse drug reaction, morbidity and mortality.
measure: Evaluation of minimal residual disease (MRD) by flow cytometry and/or molecular markers during and after treatment.
time frame: 4 years.
description: Study the immunophenotype characteristics and/or molecular markers at diagnosis, and during the different treatment phases.
measure: Feasibility of post-remission treatment in patients with 60 or more years old.
time frame: 4 years.
description: Study the effect of post-remission treatments in patients with more than 60 years to evaluate the success of consolidation treatments.
arm group label: Risk-adapted postremission treatment.
arm group type: Other
description: Ara-C, G-CSF, Autologous peripheral blood stem cell transplantation, Allogeneic matched related or unrelated donor transplant, G-CSF Priming, CD34+ selection, Myeloablative or reduced intensity conditioning, Mylotarg purging before autologous PBSC transplantation.
intervention type: Drug
intervention name: Ara-C
description: Intermediate dose during induction phase to remission.
High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.
arm group label: Risk-adapted postremission treatment.
intervention type: Other
intervention name: Autologous peripheral blood stem cell transplantation.
description: In patients with favorable cytogenetics with a Leukocyte index above 20.
Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor.
arm group label: Risk-adapted postremission treatment.
intervention type: Other
intervention name: Allogeneic matched related or unrelated donor transplant.
description: -Patients without favorable/intermediate characteristics.
arm group label: Risk-adapted postremission treatment.
intervention type: Drug
intervention name: G-CSF
description: Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L.
Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L.
arm group label: Risk-adapted postremission treatment.
other name: Filgastrim.
intervention type: Other
intervention name: CD34+ selection.
description: -Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
arm group label: Risk-adapted postremission treatment.
intervention type: Other
intervention name: Mylotarg purging before autologous PBSC transplantation
description: Patients without favorable/intermediate characteristics and without matched related donor.
arm group label: Risk-adapted postremission treatment.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jorge Sierra, MD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Salut Brunet, MD
role: Study Chair
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Gemtuzumab