xml: <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/NCT06004765</url>
    </required_header>
    <id_info>
      <org_study_id>Len+Aza-MDS-RS</org_study_id>
      <nct_id>NCT06004765</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS</brief_title>
    <official_title>A Prospective Single-center Study on the Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        At present, the main therapies for myelodysplastic syndromes with ring sideroblasts (MDS-RS)&#xD;
        are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron&#xD;
        chelation therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including&#xD;
        direct targeting of MDS clones, immunomodulation, erythropoiesis restoration, and&#xD;
        angiogenesis inhibition. A Phase III, randomized, placebo-controlled trial of oral&#xD;
        azacitidine (AZA) in lower-risk MDS reported higher rates of hemoglobin and platelet&#xD;
        hematological improvement in patients with AZA monotherapy. Therefore, this study intended to&#xD;
        investigate the efficacy and safety of lenalidomide and sequential AZA in the treatment of&#xD;
        refractory MDS-RS versus azacitidine monotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Myelodysplastic neoplasms (MDS) are heterogeneous clonal disorders of stem cells that result&#xD;
        in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the&#xD;
        development of acute myeloid leukemia (AML). Most patients with myelodysplastic syndromes&#xD;
        with ring sideroblasts (MDS-RS) are stratified into lower-risk groups by the revised&#xD;
        International Prognostic Scoring System (IPSS). At present, the main therapies for MDS-RS are&#xD;
        red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation&#xD;
        therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including direct&#xD;
        targeting of MDS clones, immunomodulation, erythropoiesis restoration, and angiogenesis&#xD;
        inhibition. Hypomethylating agents (HMA) like azacytidine (AZA) and decitabine (DEC), have&#xD;
        been shown to improve survival or delay disease progression in high-risk MDS. A Phase III,&#xD;
        randomized, placebo-controlled trial of oral AZA in lower-risk MDS reported higher rates of&#xD;
        hemoglobin and platelet hematological improvement in patients with AZA monotherapy (24.3% vs&#xD;
        6.5%). Therefore, this study intended to investigate the efficacy and safety of lenalidomide&#xD;
        and sequential azacitidine in the treatment of refractory MDS-RS versus azacitidine&#xD;
        monotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>overall response rate (ORR)</measure>
      <time_frame>3, 6 months</time_frame>
      <description>Proportion of patients achieved complete response, partial response, and hematological improvement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>complete response rate</measure>
      <time_frame>3, 6 months</time_frame>
      <description>Proportion of patients achieved complete response.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>relapse free survival (RFS)</measure>
      <time_frame>3, 6, 12, 24 months</time_frame>
      <description>Relapse free survival will be calculated from the date of response to the date of first recorded relapse or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>3, 6, 12, 24 months</time_frame>
      <description>OS is calculated for all patients from the date of initial registration to the date of death from any cause.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Myelodysplastic Syndromes</condition>
    <arm_group>
      <arm_group_label>lenalidomide and sequential azacitidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lenalidomide (10mg/d *21 days, 28 days for 1 course), at least 2 courses. If effective, continue to use lenalidomide until ineffective or intolerant. Patients receive azacitidine (75mg/m2/d*5 days, 28 days for 1 course). Until progression or intolerance. At least 2 sessions of treatment are needed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>azacitidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Azacitidine (75mg/m2/d*5 days, 28 days for 1 course) for at least 4 courses</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lenalidomide</intervention_name>
      <description>10mg/d *21 days, 28 days for 1 course</description>
      <arm_group_label>lenalidomide and sequential azacitidine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Azacitidine</intervention_name>
      <description>75mg/m2/d*5 days, 28 days for 1 course</description>
      <arm_group_label>azacitidine</arm_group_label>
      <arm_group_label>lenalidomide and sequential azacitidine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt;18 years old.&#xD;
  &#xD;
            2. Patients with a definite diagnosis of MDS-RS and stratified as lower-risk according to&#xD;
               IPSS-R.&#xD;
  &#xD;
            3. After at least 3 months of rhEPO treatment, with hemoglobin&lt;90g/L, absolute neutrophil&#xD;
               count≥1.0× 109 /L, and platelet≥30× 109 /L&#xD;
  &#xD;
            4. Unconditional hematopoietic stem cell transplantation&#xD;
  &#xD;
            5. Adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase&#xD;
               (AST) levels within 2 times of the normal upper limit and total bilirubin levels&#xD;
               within 2 times of the normal upper limit.&#xD;
  &#xD;
          5. No active infection; Not pregnant or breastfeeding 6. ECOG≦2 with an expected life span&#xD;
          of more than 6 months 7. Documented patient consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Proliferative (white blood cell count ≥12× 109 /L) chronic myelomonocytic leukemia.&#xD;
  &#xD;
            2. Complicated with active or uncontrolled infections.&#xD;
  &#xD;
            3. Complicated with other malignancies.&#xD;
  &#xD;
            4. Creatinine/transaminase ≥ 2 normal upper limit.&#xD;
  &#xD;
            5. Complicated with myelofibrosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bing Han</last_name>
      <phone>13601059938</phone>
      <email>hanbing_li@sina.com.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking union medical college hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.</citation>
      <PMID>27069254</PMID>
    </reference>
    <reference>
      <citation>Eisenmann KM, Dykema KJ, Matheson SF, Kent NF, DeWard AD, West RA, Tibes R, Furge KA, Alberts AS. 5q- myelodysplastic syndromes: chromosome 5q genes direct a tumor-suppression network sensing actin dynamics. Oncogene. 2009 Oct 1;28(39):3429-41. doi: 10.1038/onc.2009.207. Epub 2009 Jul 13.</citation>
      <PMID>19597464</PMID>
    </reference>
    <reference>
      <citation>Kotla V, Goel S, Nischal S, Heuck C, Vivek K, Das B, Verma A. Mechanism of action of lenalidomide in hematological malignancies. J Hematol Oncol. 2009 Aug 12;2:36. doi: 10.1186/1756-8722-2-36.</citation>
      <PMID>19674465</PMID>
    </reference>
    <reference>
      <citation>Quach H, Ritchie D, Stewart AK, Neeson P, Harrison S, Smyth MJ, Prince HM. Mechanism of action of immunomodulatory drugs (IMiDS) in multiple myeloma. Leukemia. 2010 Jan;24(1):22-32. doi: 10.1038/leu.2009.236. Epub 2009 Nov 12.</citation>
      <PMID>19907437</PMID>
    </reference>
    <reference>
      <citation>Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6.</citation>
      <PMID>10384139</PMID>
    </reference>
    <reference>
      <citation>Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Canizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lubbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellstrom-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.</citation>
      <PMID>21753188</PMID>
    </reference>
    <reference>
      <citation>Santini V, Almeida A, Giagounidis A, Gropper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Canizo C, Gattermann N, Ozawa K, Risueno A, MacBeth KJ, Zhong J, Seguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.</citation>
      <PMID>27354480</PMID>
    </reference>
    <reference>
      <citation>Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Oliva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.</citation>
      <PMID>33764805</PMID>
    </reference>
    <reference>
      <citation>Silverman LR, Demakos EP, Peterson BL, Kornblith AB, Holland JC, Odchimar-Reissig R, Stone RM, Nelson D, Powell BL, DeCastro CM, Ellerton J, Larson RA, Schiffer CA, Holland JF. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002 May 15;20(10):2429-40. doi: 10.1200/JCO.2002.04.117.</citation>
      <PMID>12011120</PMID>
    </reference>
    <reference>
      <citation>Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.</citation>
      <PMID>19230772</PMID>
    </reference>
    <reference>
      <citation>Kantarjian H, Issa JP, Rosenfeld CS, Bennett JM, Albitar M, DiPersio J, Klimek V, Slack J, de Castro C, Ravandi F, Helmer R 3rd, Shen L, Nimer SD, Leavitt R, Raza A, Saba H. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Cancer. 2006 Apr 15;106(8):1794-803. doi: 10.1002/cncr.21792.</citation>
      <PMID>16532500</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Bing Han</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myelodysplastic Syndromes</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lenalidomide</mesh_term>
      <mesh_term>Azacitidine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004765
  org study id: Len+Aza-MDS-RS
  nct id: NCT06004765
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  At present, the main therapies for myelodysplastic syndromes with ring sideroblasts (MDS-RS)
        are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron
        chelation therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including
        direct targeting of MDS clones, immunomodulation, erythropoiesis restoration, and
        angiogenesis inhibition. A Phase III, randomized, placebo-controlled trial of oral
        azacitidine (AZA) in lower-risk MDS reported higher rates of hemoglobin and platelet
        hematological improvement in patients with AZA monotherapy. Therefore, this study intended to
        investigate the efficacy and safety of lenalidomide and sequential AZA in the treatment of
        refractory MDS-RS versus azacitidine monotherapy.
  Myelodysplastic neoplasms (MDS) are heterogeneous clonal disorders of stem cells that result
        in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the
        development of acute myeloid leukemia (AML). Most patients with myelodysplastic syndromes
        with ring sideroblasts (MDS-RS) are stratified into lower-risk groups by the revised
        International Prognostic Scoring System (IPSS). At present, the main therapies for MDS-RS are
        red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation
        therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including direct
        targeting of MDS clones, immunomodulation, erythropoiesis restoration, and angiogenesis
        inhibition. Hypomethylating agents (HMA) like azacytidine (AZA) and decitabine (DEC), have
        been shown to improve survival or delay disease progression in high-risk MDS. A Phase III,
        randomized, placebo-controlled trial of oral AZA in lower-risk MDS reported higher rates of
        hemoglobin and platelet hematological improvement in patients with AZA monotherapy (24.3% vs
        6.5%). Therefore, this study intended to investigate the efficacy and safety of lenalidomide
        and sequential azacitidine in the treatment of refractory MDS-RS versus azacitidine
        monotherapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: overall response rate (ORR)
  time frame: 3, 6 months
  description: Proportion of patients achieved complete response, partial response, and hematological improvement.
  measure: complete response rate
  time frame: 3, 6 months
  description: Proportion of patients achieved complete response.
  measure: relapse free survival (RFS)
  time frame: 3, 6, 12, 24 months
  description: Relapse free survival will be calculated from the date of response to the date of first recorded relapse or death from any cause.
  measure: Overall survival (OS)
  time frame: 3, 6, 12, 24 months
  description: OS is calculated for all patients from the date of initial registration to the date of death from any cause.
  arm group label: lenalidomide and sequential azacitidine
  arm group type: Experimental
  description: Lenalidomide (10mg/d *21 days, 28 days for 1 course), at least 2 courses. If effective, continue to use lenalidomide until ineffective or intolerant. Patients receive azacitidine (75mg/m2/d*5 days, 28 days for 1 course). Until progression or intolerance. At least 2 sessions of treatment are needed.
  arm group label: azacitidine
  arm group type: Experimental
  description: Azacitidine (75mg/m2/d*5 days, 28 days for 1 course) for at least 4 courses
  intervention type: Drug
  intervention name: Lenalidomide
  description: 10mg/d *21 days, 28 days for 1 course
  arm group label: lenalidomide and sequential azacitidine
  intervention type: Drug
  intervention name: Azacitidine
  description: 75mg/m2/d*5 days, 28 days for 1 course
  arm group label: azacitidine
  arm group label: lenalidomide and sequential azacitidine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bing Han
  phone: 13601059938
  email: hanbing_li@sina.com.cn
  facility: 
  country: China
  citation: Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
  PMID: 27069254
  citation: Eisenmann KM, Dykema KJ, Matheson SF, Kent NF, DeWard AD, West RA, Tibes R, Furge KA, Alberts AS. 5q- myelodysplastic syndromes: chromosome 5q genes direct a tumor-suppression network sensing actin dynamics. Oncogene. 2009 Oct 1;28(39):3429-41. doi: 10.1038/onc.2009.207. Epub 2009 Jul 13.
  PMID: 19597464
  citation: Kotla V, Goel S, Nischal S, Heuck C, Vivek K, Das B, Verma A. Mechanism of action of lenalidomide in hematological malignancies. J Hematol Oncol. 2009 Aug 12;2:36. doi: 10.1186/1756-8722-2-36.
  PMID: 19674465
  citation: Quach H, Ritchie D, Stewart AK, Neeson P, Harrison S, Smyth MJ, Prince HM. Mechanism of action of immunomodulatory drugs (IMiDS) in multiple myeloma. Leukemia. 2010 Jan;24(1):22-32. doi: 10.1038/leu.2009.236. Epub 2009 Nov 12.
  PMID: 19907437
  citation: Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6.
  PMID: 10384139
  citation: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Canizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lubbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellstrom-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.
  PMID: 21753188
  citation: Santini V, Almeida A, Giagounidis A, Gropper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Canizo C, Gattermann N, Ozawa K, Risueno A, MacBeth KJ, Zhong J, Seguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.
  PMID: 27354480
  citation: Garcia-Manero G, Santini V, Almeida A, Platzbecker U, Jonasova A, Silverman LR, Falantes J, Reda G, Buccisano F, Fenaux P, Buckstein R, Diez Campelo M, Larsen S, Valcarcel D, Vyas P, Giai V, Oliva EN, Shortt J, Niederwieser D, Mittelman M, Fianchi L, La Torre I, Zhong J, Laille E, Lopes de Menezes D, Skikne B, Beach CL, Giagounidis A. Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes. J Clin Oncol. 2021 May 1;39(13):1426-1436. doi: 10.1200/JCO.20.02619. Epub 2021 Mar 25.
  PMID: 33764805
  citation: Silverman LR, Demakos EP, Peterson BL, Kornblith AB, Holland JC, Odchimar-Reissig R, Stone RM, Nelson D, Powell BL, DeCastro CM, Ellerton J, Larson RA, Schiffer CA, Holland JF. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002 May 15;20(10):2429-40. doi: 10.1200/JCO.2002.04.117.
  PMID: 12011120
  citation: Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.
  PMID: 19230772
  citation: Kantarjian H, Issa JP, Rosenfeld CS, Bennett JM, Albitar M, DiPersio J, Klimek V, Slack J, de Castro C, Ravandi F, Helmer R 3rd, Shen L, Nimer SD, Leavitt R, Raza A, Saba H. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Cancer. 2006 Apr 15;106(8):1794-803. doi: 10.1002/cncr.21792.
  PMID: 16532500
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Bing Han
  investigator title: professor
  mesh term: Myelodysplastic Syndromes
  mesh term: Lenalidomide
  mesh term: Azacitidine
  sharing ipd: No