<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/NCT01681563</url>
  </required_header>
  <id_info>
    <org_study_id>PCO</org_study_id>
    <secondary_id>2010-022332-37</secondary_id>
    <nct_id>NCT01681563</nct_id>
  </id_info>
  <brief_title>Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia</brief_title>
  <official_title>A Single-arm Multi-center Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Niguarda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regione Lombardia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospira, now a wholly owned subsidiary of Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Niguarda Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II multicenter, non-comparative, open label study in older previously&#xD;
      untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the&#xD;
      efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination&#xD;
      with Ofatumumab (PCO).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic lymphocytic leukemia (CLL) is the most common of the chronic lymphoid leukemias,&#xD;
      comprising 30% of all adult leukemias. The majority of CLL patients are of advanced age.&#xD;
      Currently, immunochemotherapy with Rituximab, Fludarabine and Cyclophosphamide (RFC) is the&#xD;
      standard of care in previously untreated patients with CLL requiring treatment. The&#xD;
      combination of Pentostatin and Cyclophosphamide has generated excellent clinical response&#xD;
      rates in pretreated B-CLL patients. Early data on the use of Ofatumumab as a single agent in&#xD;
      Fludarabine-refractory CLL patients have been reported. Given the reported efficacy of&#xD;
      chemo-immunotherapy combinations in CLL and the promising activity and toxicity profile of&#xD;
      Pentostatin combinations, we designed a trial of Pentostatin, Cyclophosphamide, and&#xD;
      Ofatumumab for previously untreated older patients with CLL. The aim is improving efficacy,&#xD;
      in Rituximab resistant CLL, and toxicity considering the good profile of tolerability showed&#xD;
      using Ofatumumab as single agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Overall Response Rate (ORR)</measure>
    <time_frame>2 months after the last dose received (End of treatment period)</time_frame>
    <description>To assess the overall response rate (ORR) using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL requiring therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events according to CTCAE, Version 3.0 NCI CTCAE</measure>
    <time_frame>From informed consent signed through to 28 days after the last study drug administration</time_frame>
    <description>To monitor and assess toxicity of pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CRR)</measure>
    <time_frame>Baseline, at cycle 3 and 2 months after the last dose received</time_frame>
    <description>To assess the complete response of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal Residual Disease (MRD)</measure>
    <time_frame>Every 3 months from the last dose of treatment up to 2 years follow up.</time_frame>
    <description>To determine the proportion of patients who achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry.It will be assessed only in patients responding to PCO treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>Measured as the time from inclusion in the trial to disease progression or death, assessed up to 2 years</time_frame>
    <description>To determine the progression-free survival in CLL patients treated with pentostatin,cyclophosphamide, and ofatumumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Measured as the time from inclusion in the trial until death from any cause, assessed up to 2 years of follow up</time_frame>
    <description>To assess overall survival (OS) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time To Progression (TTP)</measure>
    <time_frame>Measured as the time from inclusion in the trial until disease progression or death, assessed up to 2 years</time_frame>
    <description>To assess the time-to-progression (TTP) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic analysis by Fish</measure>
    <time_frame>Baseline, 2 months after the last dose received and at month 12 and 24 during follow up</time_frame>
    <description>To determine if cytogenetic abnormalities identified by FISH, relate to response to PCO therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ofatumumab pharmacokinetics parameter</measure>
    <time_frame>Cycle1: Day 1, 2, 3, 8, 9, 15. Cycles 2-5: Day 1, 2, 3, 8,15. Cycle 6: Day 1, 2, 3, 8, 15, 21</time_frame>
    <description>To assess ofatumumab pharmacokinetic parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgVH mutation status</measure>
    <time_frame>Baseline, 2 months after the last dose received and at month 12 and 24 during follow up</time_frame>
    <description>To determine if IgVH mutation status relate to response to PCO therapy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>Pentostatin/Cyclophosphamide/Ofatumumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive up to 6 cycles of pentostatin, cyclophosphamide, and ofatumumab given every 21 days (+/- 4 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentostatin</intervention_name>
    <description>Lyophilized powder for intravenous administration.</description>
    <arm_group_label>Pentostatin/Cyclophosphamide/Ofatumumab</arm_group_label>
    <other_name>Nipent 10 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>IV</description>
    <arm_group_label>Pentostatin/Cyclophosphamide/Ofatumumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ofatumumab</intervention_name>
    <description>Liquid concentrate for solution for infusion.</description>
    <arm_group_label>Pentostatin/Cyclophosphamide/Ofatumumab</arm_group_label>
    <other_name>Arzerra 100 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of B-CLL defined by:&#xD;
&#xD;
               1. Circulating lymphocytes of more than or equal to 5 x109/L B lymphocytes (5000/mL)&#xD;
                  in the peripheral blood for the duration of at least 3 months. AND&#xD;
&#xD;
               2. Flow cytometry confirmation of immunophenotype: CD5, CD19, CD20, CD23, CD79b, and&#xD;
                  surface Ig&#xD;
&#xD;
          -  Age ≥ 65 years&#xD;
&#xD;
          -  Active disease and indication for treatment based on modified NCI-WG guidelines&#xD;
             defined by presenting at least any one of the following conditions:&#xD;
&#xD;
          -  Evidence of progressive marrow failure as manifested by development of, or worsening&#xD;
             of anemia and/or thrombocytopenia&#xD;
&#xD;
          -  Massive (i.e. &gt; 6 cm below the left costal margin) or progressive or symptomatic&#xD;
             splenomegaly&#xD;
&#xD;
          -  Massive nodes (i.e. &gt; 10 cm in longest diameter) or progressive or symptomatic&#xD;
             lymphadenopathy&#xD;
&#xD;
          -  Progressive lymphocytosis with an increase of &gt; 50% over a two month period or an&#xD;
             lymphocyte doubling time &lt; 6 months&#xD;
&#xD;
          -  A minimum of any one of the following disease-related symptoms must be present:&#xD;
&#xD;
               1. Unintentional Weight loss ³ 10% within the previous six months&#xD;
&#xD;
               2. Fevers &gt; 38.0 °C for ≥ 2 weeks without evidence of infection&#xD;
&#xD;
               3. Night sweats for more than 1 month without evidence of infection&#xD;
&#xD;
          -  Not been previously treated for B-CLL (prior autoimmune hemolytic anemia treatment&#xD;
             permitted)&#xD;
&#xD;
          -  ECOG Performance Status of 0-2&#xD;
&#xD;
          -  Signed written informed consent prior to performing any study-specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy for B-CLL with any agent except corticosteroids used to treat autoimmune&#xD;
             hemolytic anemia&#xD;
&#xD;
          -  Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy &gt; 100 mg&#xD;
             equivalent to hydrocortisone, or chemotherapy&#xD;
&#xD;
          -  Known Richter transformation&#xD;
&#xD;
          -  Known CNS involvement of B-CLL&#xD;
&#xD;
          -  Any radiation therapy ≤ 4 weeks prior to registration;&#xD;
&#xD;
          -  Any major surgery ≤ 4 weeks prior to registration;&#xD;
&#xD;
          -  Chronic or current infectious disease requiring systemic antibiotics, antifungal, or&#xD;
             antiviral treatment such as, but not limited to, chronic renal infection, chronic&#xD;
             chest infection with bronchiectasis, tuberculosis and active Hepatitis C&#xD;
&#xD;
          -  Past or current malignancy with the exception of basal cell carcinoma of the skin or&#xD;
             in situ carcinoma of the cervix or the breast unless the tumor was successfully&#xD;
             treated with curative intend at least 2 years prior to trial entry.&#xD;
&#xD;
          -  Clinically significant cardiac disease including unstable angina, acute myocardial&#xD;
             infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia&#xD;
             requiring therapy, with the exception of extra systoles or minor conduction&#xD;
             abnormalities&#xD;
&#xD;
          -  History of significant cerebrovascular disease&#xD;
&#xD;
          -  Glucocorticoid unless given in doses ≤ 100 mg/day hydrocortisone (or equivalent dose&#xD;
             of other glucocorticoid) if for exacerbations other than B-CLL (e.g. asthma)&#xD;
&#xD;
          -  Known HIV positive&#xD;
&#xD;
          -  Positive serology for Hepatitis B (HB), defined as a positive test for HBsAg. In&#xD;
             addition if negative for HBsAg but HBcAb positive and HBsAb negative a HB DNA test&#xD;
             will be performed and if positive the subject will be excluded. Note: if HBcAb&#xD;
             positive and HBsAb positive, which is indicative of a past infection, the subject can&#xD;
             be included.&#xD;
&#xD;
          -  Screening laboratory values:&#xD;
&#xD;
               1. Creatinine Clearance &lt; 60 mL/min&#xD;
&#xD;
               2. Total bilirubin &gt; 2.0 times upper normal limit (unless due to liver involvement&#xD;
                  of BCLL)&#xD;
&#xD;
               3. ALT &gt; 3.0 times upper normal limit (unless due to liver involvement of B-CLL)&#xD;
&#xD;
          -  Treatment with any non-marketed drug substance or experimental therapy within 4 weeks&#xD;
             prior to Visit 1 or currently participating in any other interventional clinical study&#xD;
&#xD;
          -  Known or suspected inability to comply with the study protocol&#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>Marco Montillo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ospedale Cà Granda - Niguarda S.C: Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Agostino Cortelezzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Maggiore Policlinico Università di Milano Istituto di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giovanni Ucci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASL della provincia di Lodi Presidio Ospedaliero di Lodi Dipartimento di Medicina Interna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ester Orlandi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Policlinico San Matteo Pavia Istituto di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fausto Rossini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera San Gerardo di Monza U.O. Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Armando Santoro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Clinico Humanitas di Rozzano Dipartimento di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo Ghia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Ospedale S. Raffaele Università Vita-Salute Dipartimento di Medicina Interna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marina Motta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Presidi Ospedalieri Spedali Civili di Brescia Divisione di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gianluca Gaidano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria Maggiore della Carità - Struttura Complessa a Direzione Universitaria (SCDU Ematologia)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mauro Turrini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Valduce S.C. Medicina Interna Sezione di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierangelo Spedini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituti Ospitalieri di Cremona U.O.Complessa di Ematologia e CTMO</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marta Coscia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOU Città della Salute e della Scienza Ospedale Molinette Divisione di Ematologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonino Mazzone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Ospedale Civile di Legnano U.O. Medicina Interna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandro Rambaldi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>A.O. Papa Giovanni XXIII di Bergamo USC Ematologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Gerardo di Monza U.O. Ematologia</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20052</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto clinico Humanitas di Rozzano Dipartimento di Ematologia</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Civile di Legnano U.O. Medicina Interna</name>
      <address>
        <city>Legnano</city>
        <state>MI</state>
        <zip>20025</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Papa Giovanni XXIII U.S.C. Ematologia</name>
      <address>
        <city>Bergamo</city>
        <zip>24128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidi Ospedalieri Spedali Civili di Brescia Divisione di Ematologia</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Valduce S.C. Medicina Interna Sez. Ematologia</name>
      <address>
        <city>Como</city>
        <zip>22100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore Policlinico Università di Milano Istituto di Ematologia</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Fondazione Centro S. Raffaele del Monte Tabor Università Vita-Salute Dipartimento di Medicina Interna</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cà Granda - Niguarda S.C: Ematologia</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaliera-universitaria Maggiore della Carità SCDU Ematologia</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Matteo Pavia Istituto di Ematologia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza Ospedale Molinette Divisione di Ematologia</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Cyclophosphamide</mesh_term>
    <mesh_term>Ofatumumab</mesh_term>
    <mesh_term>Pentostatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01681563
org study id: PCO
secondary id: 2010-022332-37
nct id: NCT01681563
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a phase II multicenter, non-comparative, open label study in older previously
      untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the
      efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination
      with Ofatumumab (PCO).
Chronic lymphocytic leukemia (CLL) is the most common of the chronic lymphoid leukemias,
      comprising 30% of all adult leukemias. The majority of CLL patients are of advanced age.
      Currently, immunochemotherapy with Rituximab, Fludarabine and Cyclophosphamide (RFC) is the
      standard of care in previously untreated patients with CLL requiring treatment. The
      combination of Pentostatin and Cyclophosphamide has generated excellent clinical response
      rates in pretreated B-CLL patients. Early data on the use of Ofatumumab as a single agent in
      Fludarabine-refractory CLL patients have been reported. Given the reported efficacy of
      chemo-immunotherapy combinations in CLL and the promising activity and toxicity profile of
      Pentostatin combinations, we designed a trial of Pentostatin, Cyclophosphamide, and
      Ofatumumab for previously untreated older patients with CLL. The aim is improving efficacy,
      in Rituximab resistant CLL, and toxicity considering the good profile of tolerability showed
      using Ofatumumab as single agent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: 2 months after the last dose received (End of treatment period)
description: To assess the overall response rate (ORR) using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL requiring therapy.
measure: Adverse Events according to CTCAE, Version 3.0 NCI CTCAE
time frame: From informed consent signed through to 28 days after the last study drug administration
description: To monitor and assess toxicity of pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL.
measure: Complete Response Rate (CRR)
time frame: Baseline, at cycle 3 and 2 months after the last dose received
description: To assess the complete response of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
measure: Minimal Residual Disease (MRD)
time frame: Every 3 months from the last dose of treatment up to 2 years follow up.
description: To determine the proportion of patients who achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry.It will be assessed only in patients responding to PCO treatment.
measure: Progression-Free Survival
time frame: Measured as the time from inclusion in the trial to disease progression or death, assessed up to 2 years
description: To determine the progression-free survival in CLL patients treated with pentostatin,cyclophosphamide, and ofatumumab.
measure: Overall Survival (OS)
time frame: Measured as the time from inclusion in the trial until death from any cause, assessed up to 2 years of follow up
description: To assess overall survival (OS) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
measure: Time To Progression (TTP)
time frame: Measured as the time from inclusion in the trial until disease progression or death, assessed up to 2 years
description: To assess the time-to-progression (TTP) of CLL patients treated with pentostatin, cyclophosphamide, and ofatumumab
measure: Genetic analysis by Fish
time frame: Baseline, 2 months after the last dose received and at month 12 and 24 during follow up
description: To determine if cytogenetic abnormalities identified by FISH, relate to response to PCO therapy.
measure: Ofatumumab pharmacokinetics parameter
time frame: Cycle1: Day 1, 2, 3, 8, 9, 15. Cycles 2-5: Day 1, 2, 3, 8,15. Cycle 6: Day 1, 2, 3, 8, 15, 21
description: To assess ofatumumab pharmacokinetic parameters
measure: IgVH mutation status
time frame: Baseline, 2 months after the last dose received and at month 12 and 24 during follow up
description: To determine if IgVH mutation status relate to response to PCO therapy
arm group label: Pentostatin/Cyclophosphamide/Ofatumumab
arm group type: Experimental
description: Subjects will receive up to 6 cycles of pentostatin, cyclophosphamide, and ofatumumab given every 21 days (+/- 4 days).
intervention type: Drug
intervention name: Pentostatin
description: Lyophilized powder for intravenous administration.
arm group label: Pentostatin/Cyclophosphamide/Ofatumumab
other name: Nipent 10 mg
intervention type: Drug
intervention name: Cyclophosphamide
description: IV
arm group label: Pentostatin/Cyclophosphamide/Ofatumumab
intervention type: Drug
intervention name: Ofatumumab
description: Liquid concentrate for solution for infusion.
arm group label: Pentostatin/Cyclophosphamide/Ofatumumab
other name: Arzerra 100 mg
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Montillo, MD
role: Study Director
affiliation: Ospedale Cà Granda - Niguarda S.C: Ematologia
last name: Agostino Cortelezzi, MD
role: Principal Investigator
affiliation: Ospedale Maggiore Policlinico Università di Milano Istituto di Ematologia
last name: Giovanni Ucci, MD
role: Principal Investigator
affiliation: ASL della provincia di Lodi Presidio Ospedaliero di Lodi Dipartimento di Medicina Interna
last name: Ester Orlandi, MD
role: Principal Investigator
affiliation: IRCCS Policlinico San Matteo Pavia Istituto di Ematologia
last name: Fausto Rossini, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera San Gerardo di Monza U.O. Ematologia
last name: Armando Santoro, MD
role: Principal Investigator
affiliation: IRCCS Istituto Clinico Humanitas di Rozzano Dipartimento di Ematologia
last name: Paolo Ghia, MD
role: Principal Investigator
affiliation: IRCCS Ospedale S. Raffaele Università Vita-Salute Dipartimento di Medicina Interna
last name: Marina Motta, MD
role: Principal Investigator
affiliation: Presidi Ospedalieri Spedali Civili di Brescia Divisione di Ematologia
last name: Gianluca Gaidano, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria Maggiore della Carità - Struttura Complessa a Direzione Universitaria (SCDU Ematologia)
last name: Mauro Turrini, MD
role: Principal Investigator
affiliation: Ospedale Valduce S.C. Medicina Interna Sezione di Ematologia
last name: Pierangelo Spedini, MD
role: Principal Investigator
affiliation: Istituti Ospitalieri di Cremona U.O.Complessa di Ematologia e CTMO
last name: Marta Coscia, MD
role: Principal Investigator
affiliation: AOU Città della Salute e della Scienza Ospedale Molinette Divisione di Ematologia
last name: Antonino Mazzone, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Ospedale Civile di Legnano U.O. Medicina Interna
last name: Alessandro Rambaldi, MD
role: Principal Investigator
affiliation: A.O. Papa Giovanni XXIII di Bergamo USC Ematologia
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country: Italy
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Cyclophosphamide
mesh term: Ofatumumab
mesh term: Pentostatin