<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/NCT03016988</url>
  </required_header>
  <id_info>
    <org_study_id>Fujian Medical University</org_study_id>
    <nct_id>NCT03016988</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma</brief_title>
  <official_title>Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tingbo Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Union hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fujian Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival.&#xD;
      This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and&#xD;
      Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy&#xD;
      and transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed&#xD;
      MCL as defined by the World Health Organization classification; age≥18 years; Eastern&#xD;
      Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function&#xD;
      (haemoglobin &gt; 9.0 g/l, absolute neutrophil count &gt; 1500/ml, platelets &gt; 75,000/l), hepatic&#xD;
      function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine&#xD;
      aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal&#xD;
      function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation&#xD;
      function and electrocardiogram results. Stage was defined according to the Ann Arbor system.&#xD;
&#xD;
      The Fujian Medical University Union Hospital approved this study before subjects were&#xD;
      enrolled.&#xD;
&#xD;
      Treatment dosages were as follows:&#xD;
&#xD;
      days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion&#xD;
      25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was&#xD;
      repeated every 28 days for a maximum of six cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Progress-free survival</measure>
    <time_frame>Follow-up to 36 months</time_frame>
    <description>Interval from registration to progression or death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Lugano classification</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Mantle Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Bortezomib,Fludarabine and Cytarabine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib</intervention_name>
    <description>Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;</description>
    <arm_group_label>Bortezomib,Fludarabine and Cytarabine</arm_group_label>
    <other_name>Bortezomib (PS-341)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>Fludarabine(F) 25mg/m2, intravenously day 1-3;</description>
    <arm_group_label>Bortezomib,Fludarabine and Cytarabine</arm_group_label>
    <other_name>NSC 118218</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Cytarabine(A) 500mg/m2 for 3 days(day1-3)</description>
    <arm_group_label>Bortezomib,Fludarabine and Cytarabine</arm_group_label>
    <other_name>Cytosar-U</other_name>
    <other_name>Cytosine Arabinoside</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the&#xD;
             World Health Organization classification;&#xD;
&#xD;
          2. age≥18 years;&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;&#xD;
&#xD;
          4. adequate haematologic function (haemoglobin &gt; 9.0 g/l, absolute neutrophil count &gt;&#xD;
             1500/ml, platelets &gt; 75,000/l),&#xD;
&#xD;
          5. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of&#xD;
             normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper&#xD;
             limit of normal),&#xD;
&#xD;
          6. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50&#xD;
             ml/min);&#xD;
&#xD;
          7. normal coagulation function and electrocardiogram results.&#xD;
&#xD;
          8. willingness to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. MCL patients who do NOT response or are refractory to preview treatment.&#xD;
&#xD;
          2. Who do NOT sign the consent form.&#xD;
&#xD;
          3. whose life expectation is less than 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Cheah CY, Seymour JF, Wang ML. Mantle Cell Lymphoma. J Clin Oncol. 2016 Apr 10;34(11):1256-69. doi: 10.1200/JCO.2015.63.5904. Epub 2016 Jan 11.</citation>
    <PMID>26755518</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Medical University</investigator_affiliation>
    <investigator_full_name>Tingbo Liu</investigator_full_name>
    <investigator_title>Professor of medicine</investigator_title>
  </responsible_party>
  <keyword>Mantle cell lymphoma</keyword>
  <keyword>Bortezomib</keyword>
  <keyword>Fludarabine</keyword>
  <keyword>Cytarabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03016988
org study id: Fujian Medical University
nct id: NCT03016988
lead sponsor: 
collaborator: 
has dmc: Yes
Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival.
      This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and
      Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy
      and transplantation.
The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed
      MCL as defined by the World Health Organization classification; age≥18 years; Eastern
      Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function
      (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic
      function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine
      aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal
      function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation
      function and electrocardiogram results. Stage was defined according to the Ann Arbor system.

      The Fujian Medical University Union Hospital approved this study before subjects were
      enrolled.

      Treatment dosages were as follows:

      days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion
      25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was
      repeated every 28 days for a maximum of six cycles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress-free survival
time frame: Follow-up to 36 months
description: Interval from registration to progression or death from any cause
measure: Overall response rate
time frame: Up to 36 months
description: Lugano classification
arm group label: Bortezomib,Fludarabine and Cytarabine
arm group type: Other
description: Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
intervention type: Drug
intervention name: Bortezomib
description: Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
arm group label: Bortezomib,Fludarabine and Cytarabine
other name: Bortezomib (PS-341)
intervention type: Drug
intervention name: Fludarabine
description: Fludarabine(F) 25mg/m2, intravenously day 1-3;
arm group label: Bortezomib,Fludarabine and Cytarabine
other name: NSC 118218
intervention type: Drug
intervention name: Cytarabine
description: Cytarabine(A) 500mg/m2 for 3 days(day1-3)
arm group label: Bortezomib,Fludarabine and Cytarabine
other name: Cytosar-U
other name: Cytosine Arabinoside
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
citation: Cheah CY, Seymour JF, Wang ML. Mantle Cell Lymphoma. J Clin Oncol. 2016 Apr 10;34(11):1256-69. doi: 10.1200/JCO.2015.63.5904. Epub 2016 Jan 11.
PMID: 26755518
responsible party type: Sponsor-Investigator
investigator affiliation: Fujian Medical University
investigator full name: Tingbo Liu
investigator title: Professor of medicine
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
mesh term: Cytarabine
mesh term: Fludarabine
mesh term: Bortezomib
sharing ipd: Yes