<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/NCT03258866</url>
  </required_header>
  <id_info>
    <org_study_id>RTX 4v1 in ITP</org_study_id>
    <nct_id>NCT03258866</nct_id>
  </id_info>
  <brief_title>The Study of Different Dose Rituximab in the Treatment of ITP</brief_title>
  <official_title>The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The project was undertaking by Qilu Hospital of Shandong University in China. In order to&#xD;
      compare the efficacy, safety and response duration of different dose of rituximab in patients&#xD;
      primary immune thrombocytopenia(pITP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided&#xD;
      into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a&#xD;
      fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).&#xD;
      In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset&#xD;
      time, duration of efficacy and adverse reactions were observed to compare the efficacy and&#xD;
      safety of two different plans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Evaluation of platelet response(continuous response rate)</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count &lt; 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>therapy associated adverse events</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>The number and frequency of therapy associated adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Purpura, Thrombocytopenic, Idiopathic</condition>
  <condition>Immune Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In group B, Rituximab was given with a single dose of 375mg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)</description>
    <arm_group_label>group A</arm_group_label>
    <other_name>Mabthera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>given with a single dose of 375mg/m2</description>
    <arm_group_label>group B</arm_group_label>
    <other_name>Mabthera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria for immune thrombocytopenia.&#xD;
&#xD;
          2. Male or female, between the ages of 10 ~ 70 years.&#xD;
&#xD;
          3. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is&#xD;
             large, without immunosuppressive therapy or immunosuppressive treatment ineffective&#xD;
&#xD;
          4. To show a platelet count &lt; 30×10^9/L, or with bleeding manifestations.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.&#xD;
&#xD;
          2. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or&#xD;
             uncontrolled disease or condition related to or impacting cardiac function (e.g.,&#xD;
             unstable angina, congestive heart failure, uncontrolled hypertension or cardiac&#xD;
             arrhythmia)&#xD;
&#xD;
          3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate&#xD;
             pregnancy during the study period.&#xD;
&#xD;
          4. Have a known diagnosis of other autoimmune diseases, established in the medical&#xD;
             history and laboratory findings with positive results for the determination of&#xD;
             antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct&#xD;
             Coombs test.&#xD;
&#xD;
          5. Patients who are deemed unsuitable for the study by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Hou, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qilu hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Auger S, Duny Y, Rossi JF, Quittet P. Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta-analysis. Br J Haematol. 2012 Aug;158(3):386-98. doi: 10.1111/j.1365-2141.2012.09169.x. Epub 2012 May 22.</citation>
    <PMID>22612239</PMID>
  </reference>
  <reference>
    <citation>Zaja F, Volpetti S, Chiozzotto M, Puglisi S, Isola M, Buttignol S, Fanin R. Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia. Am J Hematol. 2012 Sep;87(9):886-9. doi: 10.1002/ajh.23272. Epub 2012 Jun 20.</citation>
    <PMID>22718483</PMID>
  </reference>
  <results_reference>
    <citation>Grace RF, Bennett CM, Ritchey AK, Jeng M, Thornburg CD, Lambert MP, Neier M, Recht M, Kumar M, Blanchette V, Klaassen RJ, Buchanan GR, Kurth MH, Nugent DJ, Thompson AA, Stine K, Kalish LA, Neufeld EJ. Response to steroids predicts response to rituximab in pediatric chronic immune thrombocytopenia. Pediatr Blood Cancer. 2012 Feb;58(2):221-5. doi: 10.1002/pbc.23130. Epub 2011 Jun 14.</citation>
    <PMID>21674758</PMID>
  </results_reference>
  <results_reference>
    <citation>Reboursiere E, Fouques H, Maigne G, Johnson H, Chantepie S, Gac AC, Reman O, Macro M, Benabed K, Troussard X, Damaj G, Cheze S. Rituximab salvage therapy in adults with immune thrombocytopenia: retrospective study on efficacy and safety profiles. Int J Hematol. 2016 Jul;104(1):85-91. doi: 10.1007/s12185-016-1992-4. Epub 2016 Apr 4.</citation>
    <PMID>27040278</PMID>
  </results_reference>
  <results_reference>
    <citation>Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.</citation>
    <PMID>20546023</PMID>
  </results_reference>
  <results_reference>
    <citation>Garcia-Suarez J, Prieto A, Reyes E, Manzano L, Merino JL, Alvarez-Mon M. The clinical outcome of autoimmune thrombocytopenic purpura patients is related to their T cell immunodeficiency. Br J Haematol. 1993 Jul;84(3):464-70. doi: 10.1111/j.1365-2141.1993.tb03102.x.</citation>
    <PMID>8217798</PMID>
  </results_reference>
  <results_reference>
    <citation>Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Ronnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013 Mar 14;121(11):1976-81. doi: 10.1182/blood-2012-09-455691. Epub 2013 Jan 4.</citation>
    <PMID>23293082</PMID>
  </results_reference>
  <results_reference>
    <citation>Brah S, Chiche L, Fanciullino R, Bornet C, Mancini J, Schleinitz N, Jean R, Kaplanski G, Harle JR, Durand JM. Efficacy of rituximab in immune thrombocytopenic purpura: a retrospective survey. Ann Hematol. 2012 Feb;91(2):279-85. doi: 10.1007/s00277-011-1283-3. Epub 2011 Jun 28.</citation>
    <PMID>21710166</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <keyword>thrombocytopenia</keyword>
  <keyword>Immune Thrombocytopenia</keyword>
  <keyword>purpura</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03258866
org study id: RTX 4v1 in ITP
nct id: NCT03258866
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The project was undertaking by Qilu Hospital of Shandong University in China. In order to
      compare the efficacy, safety and response duration of different dose of rituximab in patients
      primary immune thrombocytopenia(pITP).
62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided
      into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a
      fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
      In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset
      time, duration of efficacy and adverse reactions were observed to compare the efficacy and
      safety of two different plans.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of platelet response(continuous response rate)
time frame: up to 1 year per subject
description: Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
measure: therapy associated adverse events
time frame: up to 1 year per subject
description: The number and frequency of therapy associated adverse events
arm group label: group A
arm group type: Experimental
description: In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
arm group label: group B
arm group type: Experimental
description: In group B, Rituximab was given with a single dose of 375mg/m2
intervention type: Drug
intervention name: Rituximab
description: given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
arm group label: group A
other name: Mabthera
intervention type: Drug
intervention name: Rituximab
description: given with a single dose of 375mg/m2
arm group label: group B
other name: Mabthera
criteria: 
gender: All
minimum age: 10 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ming Hou, Dr
role: Principal Investigator
affiliation: Shandong University
facility: 
country: China
citation: Auger S, Duny Y, Rossi JF, Quittet P. Rituximab before splenectomy in adults with primary idiopathic thrombocytopenic purpura: a meta-analysis. Br J Haematol. 2012 Aug;158(3):386-98. doi: 10.1111/j.1365-2141.2012.09169.x. Epub 2012 May 22.
PMID: 22612239
citation: Zaja F, Volpetti S, Chiozzotto M, Puglisi S, Isola M, Buttignol S, Fanin R. Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia. Am J Hematol. 2012 Sep;87(9):886-9. doi: 10.1002/ajh.23272. Epub 2012 Jun 20.
PMID: 22718483
citation: Grace RF, Bennett CM, Ritchey AK, Jeng M, Thornburg CD, Lambert MP, Neier M, Recht M, Kumar M, Blanchette V, Klaassen RJ, Buchanan GR, Kurth MH, Nugent DJ, Thompson AA, Stine K, Kalish LA, Neufeld EJ. Response to steroids predicts response to rituximab in pediatric chronic immune thrombocytopenia. Pediatr Blood Cancer. 2012 Feb;58(2):221-5. doi: 10.1002/pbc.23130. Epub 2011 Jun 14.
PMID: 21674758
citation: Reboursiere E, Fouques H, Maigne G, Johnson H, Chantepie S, Gac AC, Reman O, Macro M, Benabed K, Troussard X, Damaj G, Cheze S. Rituximab salvage therapy in adults with immune thrombocytopenia: retrospective study on efficacy and safety profiles. Int J Hematol. 2016 Jul;104(1):85-91. doi: 10.1007/s12185-016-1992-4. Epub 2016 Apr 4.
PMID: 27040278
citation: Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.
PMID: 20546023
citation: Garcia-Suarez J, Prieto A, Reyes E, Manzano L, Merino JL, Alvarez-Mon M. The clinical outcome of autoimmune thrombocytopenic purpura patients is related to their T cell immunodeficiency. Br J Haematol. 1993 Jul;84(3):464-70. doi: 10.1111/j.1365-2141.1993.tb03102.x.
PMID: 8217798
citation: Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Ronnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013 Mar 14;121(11):1976-81. doi: 10.1182/blood-2012-09-455691. Epub 2013 Jan 4.
PMID: 23293082
citation: Brah S, Chiche L, Fanciullino R, Bornet C, Mancini J, Schleinitz N, Jean R, Kaplanski G, Harle JR, Durand JM. Efficacy of rituximab in immune thrombocytopenic purpura: a retrospective survey. Ann Hematol. 2012 Feb;91(2):279-85. doi: 10.1007/s00277-011-1283-3. Epub 2011 Jun 28.
PMID: 21710166
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Purpura, Thrombocytopenic
mesh term: Rituximab
sharing ipd: No