<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/NCT04477486</url>
  </required_header>
  <id_info>
    <org_study_id>M20-075</org_study_id>
    <nct_id>NCT04477486</nct_id>
  </id_info>
  <brief_title>Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma</brief_title>
  <official_title>Phase 2 Study of the Efficacy and Safety of Venetoclax in Combination With Ibrutinib in Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic&#xD;
      system in blood) where cells from outer edge of the lymph nodes, called mantle zone become&#xD;
      cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Some symptoms of MCL are&#xD;
      enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. MCL is not curable&#xD;
      with standard therapies and has poor outcomes. The purpose of this study is to evaluate the&#xD;
      safety, efficacy and effect of venetoclax in combination with ibrutinib on best overall&#xD;
      response of complete response in participants with relapsed (return of disease) or refractory&#xD;
      (not responding to treatment) (R/R) MCL.&#xD;
&#xD;
      Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is&#xD;
      a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing&#xD;
      doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone.&#xD;
      Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in&#xD;
      Japan.&#xD;
&#xD;
      Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks.&#xD;
      After 104 weeks, participants will receive ibrutinib once daily until their disease&#xD;
      progresses, or they cannot tolerate the medication, or until they do not want to participate&#xD;
      in the study.&#xD;
&#xD;
      There may be a higher treatment burden for participants in this study compared to their&#xD;
      standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
      clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone&#xD;
      marrow biopsies, checking for side effects, and completing questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Anticipated">December 12, 2023</completion_date>
  <primary_completion_date type="Actual">February 9, 2022</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>Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as assessed by the Independent Review Committee (IRC)</measure>
    <time_frame>At Week 13</time_frame>
    <description>Best overall response of CR is evaluated using the complete response rate (CRR), defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, per the Revised Criteria for Response Assessment as assessed by the Independent Review Committee (IRC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the IRC</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Best Overall Response of Complete Response as assessed by the Investigator</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the Investigator</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the Investigator</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the IRC</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the Independent Review Committee (IRC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an Undetectable Minimal Residual Disease (MRD) who Achieve a Best Overall Response, as assessed by the Investigator</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Undetectable Minimal Residual Disease (MRD) in Participants who Achieve a Best Overall Response of CR, as assessed by the IRC</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment of Malignant Lymphoma, or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to Approximately 2 Years</time_frame>
    <description>OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Mantle Cell Lymphoma (MCL)</condition>
  <arm_group>
    <arm_group_label>Ibrutinib + Venetoclax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Ibrutinib Dose A + Venetoclax in various doses until a target dose is reached, for up to 104 weeks, followed by Ibrutinib monotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibrutinib</intervention_name>
    <description>Capsule; Oral</description>
    <arm_group_label>Ibrutinib + Venetoclax</arm_group_label>
    <other_name>Imbruvica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Ibrutinib + Venetoclax</arm_group_label>
    <other_name>ABT-199</other_name>
    <other_name>Venclexta</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>Venclyxto</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed Mantle Cell Lymphoma (MCL) (tumor tissue) by local testing.&#xD;
&#xD;
          -  At least 1 measurable site of disease on cross-sectional imaging that is &gt;= 2.0&#xD;
             centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions&#xD;
             per Computed Tomography (CT).&#xD;
&#xD;
          -  At least 1, but no more than 5, prior treatment regimens for MCL including at least 1&#xD;
             prior rituximab/anti-CD20 containing regimen.&#xD;
&#xD;
          -  Failure to achieve at least partial response (PR) with, or documented disease&#xD;
             progression after, the most recent treatment regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with ibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.&#xD;
&#xD;
          -  History of other malignancies, except:&#xD;
&#xD;
               -  Malignancy treated with curative intent and with no known active disease present&#xD;
                  for &gt;= 3 years before the first dose of study drug and felt to be at low risk for&#xD;
                  recurrence by treating physician.&#xD;
&#xD;
               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence&#xD;
                  of disease.&#xD;
&#xD;
               -  Adequately treated carcinoma in situ without evidence of disease.&#xD;
&#xD;
          -  History or current evidence of central nervous system lymphoma.&#xD;
&#xD;
          -  Treatment with any of the following within 7 days prior to the first dose of study&#xD;
             drug:&#xD;
&#xD;
               -  Moderate or strong cytochrome P450 3A (CYP3A) inhibitors.&#xD;
&#xD;
               -  Moderate or strong CYP3A inducers.&#xD;
&#xD;
               -  Anticancer therapy, including chemotherapy, radiotherapy, small molecule, and&#xD;
                  investigational agents, and/or monoclonal antibody &lt;=21 days prior to the first&#xD;
                  dose of study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHO Nagoya Medical Center /ID# 221958</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>460-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital /ID# 221565</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 223299</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital /ID# 221662</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital /ID# 221744</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Mito Medical Center /ID# 224912</name>
      <address>
        <city>Higashi Ibaraki-gun</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishikawa Prefectural Central Hospital /ID# 224896</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa</state>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital /ID# 221975</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital /ID# 221623</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center /ID# 224910</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital /ID# 221812</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata University Hospital /ID# 221573</name>
      <address>
        <city>Yamagata-shi</city>
        <state>Yamagata</state>
        <zip>990-9585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.rxabbvie.com/</url>
    <description>This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <disposition_first_submitted>December 21, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>December 21, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 23, 2022</disposition_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MCL</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>ABT-199</keyword>
  <keyword>Ibrutinib</keyword>
  <keyword>Imbruvica</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>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04477486
org study id: M20-075
nct id: NCT04477486
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic
      system in blood) where cells from outer edge of the lymph nodes, called mantle zone become
      cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Some symptoms of MCL are
      enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. MCL is not curable
      with standard therapies and has poor outcomes. The purpose of this study is to evaluate the
      safety, efficacy and effect of venetoclax in combination with ibrutinib on best overall
      response of complete response in participants with relapsed (return of disease) or refractory
      (not responding to treatment) (R/R) MCL.

      Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is
      a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing
      doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone.
      Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in
      Japan.

      Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks.
      After 104 weeks, participants will receive ibrutinib once daily until their disease
      progresses, or they cannot tolerate the medication, or until they do not want to participate
      in the study.

      There may be a higher treatment burden for participants in this study compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone
      marrow biopsies, checking for side effects, and completing questionnaires.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as assessed by the Independent Review Committee (IRC)
time frame: At Week 13
description: Best overall response of CR is evaluated using the complete response rate (CRR), defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, per the Revised Criteria for Response Assessment as assessed by the Independent Review Committee (IRC).
measure: Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the IRC
time frame: Up to Approximately 2 Years
description: Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.
measure: Percentage of Participants Achieving Best Overall Response of Complete Response as assessed by the Investigator
time frame: Up to Approximately 2 Years
description: Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment.
measure: Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR), as assessed by the Investigator
time frame: Up to Approximately 2 Years
description: Best Overall Response of CR or PR will be evaluated using Overall Response Rate (ORR). The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.
measure: Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the Investigator
time frame: Up to Approximately 2 Years
description: DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the investigator.
measure: Percentage of Participants Achieving Duration of Response (DOR) for a Best Overall Response, as assessed by the IRC
time frame: Up to Approximately 2 Years
description: DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment, as assessed by the Independent Review Committee (IRC).
measure: Percentage of Participants Achieving an Undetectable Minimal Residual Disease (MRD) who Achieve a Best Overall Response, as assessed by the Investigator
time frame: Up to Approximately 2 Years
description: MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the investigator.
measure: Percentage of Participants Achieving Undetectable Minimal Residual Disease (MRD) in Participants who Achieve a Best Overall Response of CR, as assessed by the IRC
time frame: Up to Approximately 2 Years
description: MRD rate is defined as the percentage of participants with undetectable MRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment, as assessed by the IRC.
measure: Progression-Free Survival (PFS)
time frame: Up to Approximately 2 Years
description: PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment of Malignant Lymphoma, or death from any cause, whichever occurs first.
measure: Overall Survival (OS)
time frame: Up to Approximately 2 Years
description: OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause.
arm group label: Ibrutinib + Venetoclax
arm group type: Experimental
description: Participants will receive Ibrutinib Dose A + Venetoclax in various doses until a target dose is reached, for up to 104 weeks, followed by Ibrutinib monotherapy.
intervention type: Drug
intervention name: Ibrutinib
description: Capsule; Oral
arm group label: Ibrutinib + Venetoclax
other name: Imbruvica
intervention type: Drug
intervention name: Venetoclax
description: Tablet; Oral
arm group label: Ibrutinib + Venetoclax
other name: ABT-199
other name: Venclexta
other name: GDC-0199
other name: Venclyxto
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://www.rxabbvie.com/
description: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
mesh term: Venetoclax
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/