<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/NCT02200978</url>
  </required_header>
  <id_info>
    <org_study_id>2010001</org_study_id>
    <nct_id>NCT02200978</nct_id>
  </id_info>
  <brief_title>A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia</brief_title>
  <official_title>A Multicenter and Randomized Prospective Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South China Children's Leukemia Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>South China Children's Leukemia Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of&#xD;
      all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy&#xD;
      (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths.&#xD;
      Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there&#xD;
      remains a subset of the patients in whom the disease relapses. Recently, a randomized&#xD;
      prospective study showed that the addition of ATO to &quot;ATRA + chemotherapy&quot; treatment protocol&#xD;
      had a significantly higher EFS in patients with APL than those treated with &quot;ATRA +&#xD;
      chemotherapy&quot; protocol. The patients treated with &quot;ATO + ATRA + chemotherapy&quot; had a five&#xD;
      years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a&#xD;
      traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and&#xD;
      tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL&#xD;
      model in vivo and in the induction of APL cell differentiation in vitro . It is about 20&#xD;
      years since RIF was used to treat ALP in China. Clinical studies showed that this agent was&#xD;
      effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken&#xD;
      orally, resulting in reducing the number of hospital days and the treatment cost. However,&#xD;
      there is no report comparing treatment outcomes of &quot;ATO + ATRA + chemotherapy&quot; and &quot;RIF +&#xD;
      ATRA + chemotherapy&quot; protocols in children with APL so far. For this purpose, therefore,&#xD;
      investigators are going to conduct a multicenter and randomized prospective study in children&#xD;
      with APL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
        -  Determine the safety and efficacy of &quot;ATO/RIF + ATRA + less intensive chemotherapy&quot;&#xD;
           protocol in children with acute promyelocytic leukemia (APL).&#xD;
&#xD;
        -  Compare the safety，efficacy and treatment cost of &quot;RIF + ATRA + less intensive&#xD;
           chemotherapy&quot; with &quot;ATO + ATRA + less intensive chemotherapy&quot; protocol in children with&#xD;
           APL. Determine if ATO can be substituted by RIF.&#xD;
&#xD;
      OUTLINE: This is a multicenter and randomized prospective study.&#xD;
&#xD;
      PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">October 2021</completion_date>
  <primary_completion_date type="Actual">October 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>event-free survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalization cost</measure>
    <time_frame>2 years</time_frame>
    <description>The cost mainly includes the fees of hospital bed, drugs, therapies and blood products. Time frame: from the beginning of induction therapy to the end of maintenance treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Childhood Acute Promyelocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction:&#xD;
ATRA 25mg/m2 d1-CR ≯42 days; ATO 0.16mg/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).&#xD;
Consolidation 1:&#xD;
ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT)：Ara-C 15mg (age &lt; 1 year), or 20 mg (1-3 years), or 30 mg ( &gt; 3 years), dexamethasone 2mg.&#xD;
Consolidation 2:&#xD;
ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.&#xD;
Consolidation 3:&#xD;
ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.&#xD;
Maintenance:&#xD;
① ATO 0.16mg/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction:&#xD;
ATRA 25mg/m2 d1-CR ≯42 days; RIF 0.135/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).&#xD;
Consolidation 1:&#xD;
ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT)：Ara-C 15mg (age &lt; 1 year), or 20mg (age 1-3 years), or 30mg (age &gt; 3 years), dexamethasone 2mg.&#xD;
Consolidation 2:&#xD;
ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.&#xD;
Consolidation 3:&#xD;
ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.&#xD;
Maintenance:&#xD;
① RIF 0.135/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATO</intervention_name>
    <description>Given IV</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <other_name>As2O3</other_name>
    <other_name>arsenic trioxide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RIF</intervention_name>
    <description>Given orally</description>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>Realgar-Indigo naturalis formula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATRA</intervention_name>
    <description>Given orally</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>all-trans retinoic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mitoxantrone</intervention_name>
    <description>Given IV</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>novantrone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ara-C</intervention_name>
    <description>Given IV</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>cytarabine</other_name>
    <other_name>cytosine arabinoside</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MTX</intervention_name>
    <description>Given orally</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>methotrexate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>6MP</intervention_name>
    <description>Given orally</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>mercaptopurine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intrathecal injection</intervention_name>
    <description>Ara-C and dexamethasone</description>
    <arm_group_label>ATO and chemotherapy</arm_group_label>
    <arm_group_label>RIF and chemotherapy</arm_group_label>
    <other_name>IT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients less than 16 years old with newly diagnosed PML-RARa positive acute&#xD;
             promyelocytic leukemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have coma, convulsion or paralysis due to intracranial hemorrhage or&#xD;
             central nervous system leukemia at diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xue-Qun Luo, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Shen ZX, Shi ZZ, Fang J, Gu BW, Li JM, Zhu YM, Shi JY, Zheng PZ, Yan H, Liu YF, Chen Y, Shen Y, Wu W, Tang W, Waxman S, De The H, Wang ZY, Chen SJ, Chen Z. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5328-35. doi: 10.1073/pnas.0400053101. Epub 2004 Mar 24.</citation>
    <PMID>15044693</PMID>
  </reference>
  <reference>
    <citation>Hu J, Liu YF, Wu CF, Xu F, Shen ZX, Zhu YM, Li JM, Tang W, Zhao WL, Wu W, Sun HP, Chen QS, Chen B, Zhou GB, Zelent A, Waxman S, Wang ZY, Chen SJ, Chen Z. Long-term efficacy and safety of all-trans retinoic acid/arsenic trioxide-based therapy in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2009 Mar 3;106(9):3342-7. doi: 10.1073/pnas.0813280106. Epub 2009 Feb 18.</citation>
    <PMID>19225113</PMID>
  </reference>
  <reference>
    <citation>Wang L, Zhou GB, Liu P, Song JH, Liang Y, Yan XJ, Xu F, Wang BS, Mao JH, Shen ZX, Chen SJ, Chen Z. Dissection of mechanisms of Chinese medicinal formula Realgar-Indigo naturalis as an effective treatment for promyelocytic leukemia. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4826-31. doi: 10.1073/pnas.0712365105. Epub 2008 Mar 14.</citation>
    <PMID>18344322</PMID>
  </reference>
  <reference>
    <citation>Xiang Y, Wang XB, Sun SJ, Guo AX, Wei AH, Cheng YB, Huang SL. [Compound huangdai tablet as induction therapy for 193 patients with acute promyelocytic leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2009 Jul;30(7):440-2. Chinese.</citation>
    <PMID>19954593</PMID>
  </reference>
  <reference>
    <citation>Luo XQ, Ke ZY, Huang LB, Guan XQ, Zhang YC, Zhang XL. Improved outcome for Chinese children with acute promyelocytic leukemia: a comparison of two protocols. Pediatr Blood Cancer. 2009 Sep;53(3):325-8. doi: 10.1002/pbc.22042.</citation>
    <PMID>19422024</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>May 7, 2022</last_update_submitted>
  <last_update_submitted_qc>May 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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, Promyelocytic, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Mercaptopurine</mesh_term>
    <mesh_term>Mitoxantrone</mesh_term>
    <mesh_term>Tretinoin</mesh_term>
    <mesh_term>Arsenic Trioxide</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/NCT02200978
org study id: 2010001
nct id: NCT02200978
lead sponsor: 
has dmc: Yes
Outcome of acute promyelocytic leukemia (APL) has greatly improved since the introduction of
      all-trans-retinoic acid (ATRA). Treatment with ATRA and anthracycline-based chemotherapy
      (ATRA + chemotherapy) decreases relapses of the disease as well as early hemorrhagic deaths.
      Nowadays patients with APL have an event-free survival (EFS) of up to 80%. However, there
      remains a subset of the patients in whom the disease relapses. Recently, a randomized
      prospective study showed that the addition of ATO to "ATRA + chemotherapy" treatment protocol
      had a significantly higher EFS in patients with APL than those treated with "ATRA +
      chemotherapy" protocol. The patients treated with "ATO + ATRA + chemotherapy" had a five
      years EFS of 89.2%. Moreover, a recent study showed that Indigo naturalis formula (RIF), a
      traditional Chinese medicine with tetraarsenic tetrasulfide (As4S4), indirubin, and
      tanshinone IIA as major active ingredients, yielded synergy in the treatment of a murine APL
      model in vivo and in the induction of APL cell differentiation in vitro . It is about 20
      years since RIF was used to treat ALP in China. Clinical studies showed that this agent was
      effective against APL. Compared to ATO, RIF is relatively inexpensive and can be taken
      orally, resulting in reducing the number of hospital days and the treatment cost. However,
      there is no report comparing treatment outcomes of "ATO + ATRA + chemotherapy" and "RIF +
      ATRA + chemotherapy" protocols in children with APL so far. For this purpose, therefore,
      investigators are going to conduct a multicenter and randomized prospective study in children
      with APL.
OBJECTIVES:

        -  Determine the safety and efficacy of "ATO/RIF + ATRA + less intensive chemotherapy"
           protocol in children with acute promyelocytic leukemia (APL).

        -  Compare the safety，efficacy and treatment cost of "RIF + ATRA + less intensive
           chemotherapy" with "ATO + ATRA + less intensive chemotherapy" protocol in children with
           APL. Determine if ATO can be substituted by RIF.

      OUTLINE: This is a multicenter and randomized prospective study.

      PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: event-free survival
time frame: 5 years
measure: hospitalization cost
time frame: 2 years
description: The cost mainly includes the fees of hospital bed, drugs, therapies and blood products. Time frame: from the beginning of induction therapy to the end of maintenance treatment.
arm group label: ATO and chemotherapy
arm group type: Active Comparator
description: Induction:
ATRA 25mg/m2 d1-CR ≯42 days; ATO 0.16mg/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).
Consolidation 1:
ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT)：Ara-C 15mg (age < 1 year), or 20 mg (1-3 years), or 30 mg ( > 3 years), dexamethasone 2mg.
Consolidation 2:
ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.
Consolidation 3:
ATRA 25mg/m2 d1-15; ATO 0.16mg/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.
Maintenance:
① ATO 0.16mg/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance.
arm group label: RIF and chemotherapy
arm group type: Experimental
description: Induction:
ATRA 25mg/m2 d1-CR ≯42 days; RIF 0.135/kg d5-CR ≯42 days; mitoxantrone (MA) 10mg/m2 d3, or 7mg/m2 d2-4 (high risk).
Consolidation 1:
ATRA 25mg/m2 d1-15; MA 10mg/m2 d1-2; Intrathecal injection (IT)：Ara-C 15mg (age < 1 year), or 20mg (age 1-3 years), or 30mg (age > 3 years), dexamethasone 2mg.
Consolidation 2:
ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; Ara-C 1g/m2 q12h d1-2 (high risk); IT.
Consolidation 3:
ATRA 25mg/m2 d1-15; RIF 0.135/kg d1-15; MA 10mg/m2 d1; Ara-C 1g/m2 q12h d1-2 (high risk); IT.
Maintenance:
① RIF 0.135/kg.d w1-2; ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. ② ATRA 25mg/m2.d w1-2; MTX 20mg/m2 qw w3-12; 6MP 50mg/m2 qn w3-12. Rotation between ① and ② until the end of maintenance treatment.
intervention type: Drug
intervention name: ATO
description: Given IV
arm group label: ATO and chemotherapy
other name: As2O3
other name: arsenic trioxide
intervention type: Drug
intervention name: RIF
description: Given orally
arm group label: RIF and chemotherapy
other name: Realgar-Indigo naturalis formula
intervention type: Drug
intervention name: ATRA
description: Given orally
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: all-trans retinoic acid
intervention type: Drug
intervention name: mitoxantrone
description: Given IV
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: novantrone
intervention type: Drug
intervention name: Ara-C
description: Given IV
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: cytarabine
other name: cytosine arabinoside
intervention type: Drug
intervention name: MTX
description: Given orally
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: methotrexate
intervention type: Drug
intervention name: 6MP
description: Given orally
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: mercaptopurine
intervention type: Other
intervention name: intrathecal injection
description: Ara-C and dexamethasone
arm group label: ATO and chemotherapy
arm group label: RIF and chemotherapy
other name: IT
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: No
last name: Xue-Qun Luo, professor
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
facility: 
country: China
citation: Shen ZX, Shi ZZ, Fang J, Gu BW, Li JM, Zhu YM, Shi JY, Zheng PZ, Yan H, Liu YF, Chen Y, Shen Y, Wu W, Tang W, Waxman S, De The H, Wang ZY, Chen SJ, Chen Z. All-trans retinoic acid/As2O3 combination yields a high quality remission and survival in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2004 Apr 13;101(15):5328-35. doi: 10.1073/pnas.0400053101. Epub 2004 Mar 24.
PMID: 15044693
citation: Hu J, Liu YF, Wu CF, Xu F, Shen ZX, Zhu YM, Li JM, Tang W, Zhao WL, Wu W, Sun HP, Chen QS, Chen B, Zhou GB, Zelent A, Waxman S, Wang ZY, Chen SJ, Chen Z. Long-term efficacy and safety of all-trans retinoic acid/arsenic trioxide-based therapy in newly diagnosed acute promyelocytic leukemia. Proc Natl Acad Sci U S A. 2009 Mar 3;106(9):3342-7. doi: 10.1073/pnas.0813280106. Epub 2009 Feb 18.
PMID: 19225113
citation: Wang L, Zhou GB, Liu P, Song JH, Liang Y, Yan XJ, Xu F, Wang BS, Mao JH, Shen ZX, Chen SJ, Chen Z. Dissection of mechanisms of Chinese medicinal formula Realgar-Indigo naturalis as an effective treatment for promyelocytic leukemia. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4826-31. doi: 10.1073/pnas.0712365105. Epub 2008 Mar 14.
PMID: 18344322
citation: Xiang Y, Wang XB, Sun SJ, Guo AX, Wei AH, Cheng YB, Huang SL. [Compound huangdai tablet as induction therapy for 193 patients with acute promyelocytic leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2009 Jul;30(7):440-2. Chinese.
PMID: 19954593
citation: Luo XQ, Ke ZY, Huang LB, Guan XQ, Zhang YC, Zhang XL. Improved outcome for Chinese children with acute promyelocytic leukemia: a comparison of two protocols. Pediatr Blood Cancer. 2009 Sep;53(3):325-8. doi: 10.1002/pbc.22042.
PMID: 19422024
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Promyelocytic, Acute
mesh term: Cytarabine
mesh term: Methotrexate
mesh term: Mercaptopurine
mesh term: Mitoxantrone
mesh term: Tretinoin
mesh term: Arsenic Trioxide