<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/NCT01724346</url>
  </required_header>
  <id_info>
    <org_study_id>PCYC-1116-CA</org_study_id>
    <secondary_id>2012-003968-44</secondary_id>
    <nct_id>NCT01724346</nct_id>
  </id_info>
  <brief_title>Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma</brief_title>
  <official_title>An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmacyclics LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pharmacyclics LLC.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia&#xD;
      (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib&#xD;
      versus Chlorambucil)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 28, 2012</start_date>
  <completion_date type="Anticipated">July 17, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 17, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>10 years</time_frame>
    <description>To monitor progression-free survival (PFS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA</measure>
    <time_frame>10 years</time_frame>
    <description>To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term follow-up and Second-line therapy monitoring</measure>
    <time_frame>10 years</time_frame>
    <description>To follow patients for long-term outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy evaluation of subsequent therapy</measure>
    <time_frame>10 years</time_frame>
    <description>To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">232</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Small Lymphocytic Lymphoma</condition>
  <arm_group>
    <arm_group_label>Arm A Post-Chlorambucil Therapy Followup</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B Ibrutinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C Second-line Ibrutinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D Alternative Anticancer Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Post-Chlorambucil Therapy Follow-up</intervention_name>
    <description>Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.</description>
    <arm_group_label>Arm A Post-Chlorambucil Therapy Followup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibrutinib</intervention_name>
    <description>Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.</description>
    <arm_group_label>Arm B Ibrutinib</arm_group_label>
    <other_name>PCI-32765</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Second-line Ibrutinib</intervention_name>
    <description>Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.</description>
    <arm_group_label>Arm C Second-line Ibrutinib</arm_group_label>
    <other_name>PCI-32765</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alternative Anticancer Treatment</intervention_name>
    <description>Specific therapy and treatment regimen are at the Investigator's discretion.</description>
    <arm_group_label>Arm A Post-Chlorambucil Therapy Followup</arm_group_label>
    <arm_group_label>Arm B Ibrutinib</arm_group_label>
    <arm_group_label>Arm C Second-line Ibrutinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alternative Anti-cancer Treatment</intervention_name>
    <description>Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.</description>
    <arm_group_label>Arm D Alternative Anticancer Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Randomized in the parent study, PCYC-1115-CA&#xD;
&#xD;
          2. Informed consent for Study PCYC-1116-CA&#xD;
&#xD;
          3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Disease progression involving the central nervous system (CNS) or transformation to&#xD;
             another histology&#xD;
&#xD;
          2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to&#xD;
             treat CLL if administered before date of IRC confirmed progressive disease&#xD;
&#xD;
          3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an&#xD;
             investigational drug&#xD;
&#xD;
          4. Requirement for treatment with a strong CYP3A inhibitor&#xD;
&#xD;
          5. Uncontrolled systemic infection or requirement for IV antibiotics&#xD;
&#xD;
          6. Noncompliance on the parent study(PCYC-1115-CA)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jim Dean, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Pharmacyclics LLC.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #047</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #408</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #720</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #038</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #125</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #126</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #071</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #307</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #387</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #221</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #712</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #350</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #127</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #656</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #734</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #677</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #050</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #032</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #381</name>
      <address>
        <city>Laredo</city>
        <state>Texas</state>
        <zip>78041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #653</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #404</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #731</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>99362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #654</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #503</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #163</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #555</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #193</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #556</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #501</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #715</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #558</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #170</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #164</name>
      <address>
        <city>Bruxelles</city>
        <state>Brussells</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #727</name>
      <address>
        <city>Yvoir</city>
        <state>Namur</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #560</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #559</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #628</name>
      <address>
        <city>Brugge</city>
        <state>West-Vlaanderen</state>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #561</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #184</name>
      <address>
        <city>Brussells</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #157</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #018</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #674</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #671</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #675</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>31003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #670</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #673</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #564</name>
      <address>
        <city>Hradec Kralove</city>
        <state>Kralovehradecky Kraj</state>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #562</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #566</name>
      <address>
        <city>Plzen-Lochotin</city>
        <zip>304 60</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #572</name>
      <address>
        <city>Dublin</city>
        <zip>7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #570</name>
      <address>
        <city>Dublin</city>
        <zip>8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #571</name>
      <address>
        <city>Galway</city>
        <zip>ST4 6QG</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #573</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #576</name>
      <address>
        <city>Haifa</city>
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      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
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  </location>
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    <facility>
      <name>Site Reference ID/Investigator #578</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
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    <facility>
      <name>Site Reference ID/Investigator #575</name>
      <address>
        <city>Petaẖ Tiqwa</city>
        <zip>49100</zip>
        <country>Israel</country>
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  </location>
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    <facility>
      <name>Site Reference ID/Investigator #574</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
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    <facility>
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        <city>Roma</city>
        <state>Lazio</state>
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        <country>Italy</country>
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    <facility>
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        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
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        <city>Novara</city>
        <state>Piemonte</state>
        <zip>28100</zip>
        <country>Italy</country>
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      <name>Site Reference ID/Investigator #527</name>
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        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
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        <city>Bologna</city>
        <zip>40138</zip>
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      <address>
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        <zip>20122</zip>
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      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
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    </facility>
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    <facility>
      <name>Site Reference ID/Investigator #581</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
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  </location>
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    <facility>
      <name>Site Reference ID/Investigator #524</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
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  </location>
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    <facility>
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        <city>Christchurch</city>
        <state>Canterbury</state>
        <zip>8011</zip>
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      </address>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #586</name>
      <address>
        <city>Hamilton</city>
        <state>Waikato</state>
        <zip>3240</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #663</name>
      <address>
        <city>Auckland</city>
        <zip>0622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #588</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #587</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #590</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #592</name>
      <address>
        <city>Brzozowie</city>
        <state>Podkarpackie</state>
        <zip>36.200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #591</name>
      <address>
        <city>Chorzow</city>
        <zip>40</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #529</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Site Reference ID/Investigator #531</name>
      <address>
        <city>Lodz</city>
        <zip>93-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #707</name>
      <address>
        <city>Ryazan</city>
        <zip>390039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #304</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #536</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #534</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #533</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #535</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #604</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #537</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #608</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #606</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #599</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #714</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #601</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #602</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #597</name>
      <address>
        <city>Cherkasy</city>
        <state>Cherkas'ka Oblast</state>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #594</name>
      <address>
        <city>Dnipropetrovsk</city>
        <state>Dnipropetrovs'ka Oblast'</state>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #725</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivs'ka Oblast</state>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #596</name>
      <address>
        <city>Lviv</city>
        <state>L'vivs'ka Oblast</state>
        <zip>79044</zip>
        <country>Ukraine</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #598</name>
      <address>
        <city>Simferopol</city>
        <state>Respublika Krym</state>
        <zip>95023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #595</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnyts'ka Oblast</state>
        <zip>21018</zip>
        <country>Ukraine</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #724</name>
      <address>
        <city>Zhytomyr</city>
        <state>Zhytomyrs'ka Oblast'</state>
        <zip>10022</zip>
        <country>Ukraine</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #551</name>
      <address>
        <city>Bournemouth</city>
        <state>Dorset</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #544</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
        <city>Oxford</city>
        <state>England</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #549</name>
      <address>
        <city>Colchester</city>
        <state>Essex</state>
        <zip>CO4 5JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #607</name>
      <address>
        <city>Cardiff</city>
        <state>South Glamergon</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #550</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #721</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #548</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator #367</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://www.pharmacyclics.com</url>
    <description>www.pharmacyclics.com</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CLL, SLL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorambucil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers</ipd_description>
  </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/NCT01724346
org study id: PCYC-1116-CA
secondary id: 2012-003968-44
nct id: NCT01724346
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia
      (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib
      versus Chlorambucil)
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label study
measure: Progression-free Survival (PFS)
time frame: 10 years
description: To monitor progression-free survival (PFS)
measure: Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
time frame: 10 years
description: To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure
measure: Long-term follow-up and Second-line therapy monitoring
time frame: 10 years
description: To follow patients for long-term outcome
measure: Efficacy evaluation of subsequent therapy
time frame: 10 years
description: To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study
arm group label: Arm A Post-Chlorambucil Therapy Followup
arm group type: Other
description: Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.
arm group label: Arm B Ibrutinib
arm group type: Experimental
description: Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
arm group label: Arm C Second-line Ibrutinib
arm group type: Experimental
description: Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
arm group label: Arm D Alternative Anticancer Therapy
arm group type: Other
description: At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).
intervention type: Drug
intervention name: Post-Chlorambucil Therapy Follow-up
description: Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.
arm group label: Arm A Post-Chlorambucil Therapy Followup
intervention type: Drug
intervention name: Ibrutinib
description: Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
arm group label: Arm B Ibrutinib
other name: PCI-32765
intervention type: Drug
intervention name: Second-line Ibrutinib
description: Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.
arm group label: Arm C Second-line Ibrutinib
other name: PCI-32765
intervention type: Drug
intervention name: Alternative Anticancer Treatment
description: Specific therapy and treatment regimen are at the Investigator's discretion.
arm group label: Arm A Post-Chlorambucil Therapy Followup
arm group label: Arm B Ibrutinib
arm group label: Arm C Second-line Ibrutinib
intervention type: Drug
intervention name: Alternative Anti-cancer Treatment
description: Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.
arm group label: Arm D Alternative Anticancer Therapy
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jim Dean, MD, PhD
role: Study Director
affiliation: Pharmacyclics LLC.
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country: Australia
country: Belgium
country: Canada
country: China
country: Czechia
country: Ireland
country: Israel
country: Italy
country: New Zealand
country: Poland
country: Russian Federation
country: Spain
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
url: http://www.pharmacyclics.com
description: www.pharmacyclics.com
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Chlorambucil
sharing ipd: No
ipd description: We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers