<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/NCT01719250</url>
  </required_header>
  <id_info>
    <org_study_id>MC1183</org_study_id>
    <secondary_id>NCI-2012-01582</secondary_id>
    <secondary_id>MC1183</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT01719250</nct_id>
  </id_info>
  <brief_title>Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma</brief_title>
  <official_title>A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well buparlisib works in treating patients with&#xD;
      non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to&#xD;
      previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the&#xD;
      enzymes needed for cell growth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the clinical benefit rate (complete response [CR], partial response [PR] or&#xD;
      standard disease [SD] &gt;= 6 months) with BKM120 (buparlisib) in patients with relapsed or&#xD;
      refractory lymphoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate overall response rate, overall survival, progression-free survival and&#xD;
      duration of response.&#xD;
&#xD;
      II. To describe the toxicities associated with BKM120 in lymphoma. III. To evaluate&#xD;
      prognostic factors for aggressive lymphoma and whether there's a correlation with clinical&#xD;
      benefit.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To assess serum cytokines before and after BKM120 therapy. II. To assess&#xD;
      phosphatidylinositol 3-kinase (PI3K) pathway member expression on paraffin-embedded tumor&#xD;
      samples pre-treatment.&#xD;
&#xD;
      III. To assess on paired fresh tumor tissue obtained from consenting patients pre- and&#xD;
      post-therapy the change in activation of PI3K pathway members.&#xD;
&#xD;
      OUTLINE: Patients receive buparlisib orally (PO) once daily (QD) on days 1-28. Courses repeat&#xD;
      every 28 days in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">March 22, 2017</completion_date>
  <primary_completion_date type="Actual">September 16, 2016</primary_completion_date>
  <phase>Early Phase 1</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>Clinical benefit defined as a PR or CR as the objective status at any time or an objective status of SD for a duration of greater than 6 months from registration</measure>
    <time_frame>From 6 months from registration up to 1 year</time_frame>
    <description>The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>From the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 1 year</time_frame>
    <description>If an adequate number of events are seen, the distribution of duration of response will be estimated using the method of Kaplan-Meier. Otherwise, duration of response will be summarized descriptively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate estimated by the number of confirmed responses (PR or CR) observed in the trial divided by the total number of evaluable patients</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Exact binomial 95% confidence intervals for the true overall response rate will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic factors for aggressive lymphoma</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will be summarized and used to help characterize the types of patients accrued to this trial. These classifications will be correlated with clinical benefit using Fisher's exact or Wilcoxon rank sum tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival time</measure>
    <time_frame>Time from registration to progression or death due to any cause, assessed up to 1 year</time_frame>
    <description>Will be estimated using the method of Kaplan-Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival time</measure>
    <time_frame>Time from registration to death due to any cause, assessed up to 1 year</time_frame>
    <description>Will be estimated using the method of Kaplan-Meier.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Recurrent Adult Diffuse Large Cell Lymphoma</condition>
  <condition>Recurrent Grade 3 Follicular Lymphoma</condition>
  <condition>Recurrent Mantle Cell Lymphoma</condition>
  <condition>Refractory Mantle Cell Lymphoma</condition>
  <condition>Transformed Recurrent Non-Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (buparlisib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive buparlisib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buparlisib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (buparlisib)</arm_group_label>
    <other_name>BKM120</other_name>
    <other_name>PI3K Inhibitor BKM120</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (buparlisib)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (buparlisib)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-proven relapsed, refractory or residual aggressive B-cell non-Hodgkin lymphoma;&#xD;
             NOTE: re-biopsy is necessary unless the patient has had a previous biopsy &lt; 168 days&#xD;
             prior to registration on this protocol and there has been no intervening treatment;&#xD;
             eligible tumor types are diffuse large B-cell non-Hodgkin lymphoma (NHL), mantle cell&#xD;
             lymphoma, transformed NHL, and follicular grade III&#xD;
&#xD;
          -  Not a candidate or has declined standard salvage therapy for their disease&#xD;
&#xD;
          -  Measurable disease as defined by at least ONE of the following:&#xD;
&#xD;
               -  Measurable disease by computed tomography (CT) or magnetic resonance imaging&#xD;
                  (MRI) or the CT portion of the positron emission tomography (PET)/CT: must have&#xD;
                  at least one lesion that has a single diameter of &gt;= 2 cm or tumor cells in the&#xD;
                  blood &gt;= 5 x 10^9/L&#xD;
&#xD;
               -  Skin lesions can be used if the area is &gt;= 2 cm in at least one diameter and&#xD;
                  photographed with a ruler&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1000/uL&#xD;
&#xD;
          -  Hemoglobin (Hgb) &gt;= 9 g/dl&#xD;
&#xD;
          -  Platelets (PLT) &gt;= 100,000/uL&#xD;
&#xD;
          -  Serum bilirubin within normal range (or =&lt; 1.5 x upper limit of normal [ULN] if liver&#xD;
             metastases are present; or total bilirubin =&lt; 3.0 x ULN with direct bilirubin within&#xD;
             normal range in patients with well documented Gilbert syndrome)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) within normal limits or =&lt; 3 x ULN if due to lymphoma&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x ULN or 24-hour clearance &gt;= 50 mL/min&#xD;
&#xD;
          -  Magnesium &gt;= lower limit of normal (LLN)&#xD;
&#xD;
          -  Potassium &gt;= LLN&#xD;
&#xD;
          -  Serum amylase =&lt; ULN&#xD;
&#xD;
          -  Serum lipase =&lt; ULN&#xD;
&#xD;
          -  Fasting plasma glucose =&lt; 120 mg/dL (6.7 mmol/L)&#xD;
&#xD;
          -  Serum calcium =&lt; 10.9 mg/dL&#xD;
&#xD;
          -  Negative pregnancy test done =&lt; 72 hours prior to starting drug, for women of&#xD;
             childbearing potential only&#xD;
&#xD;
          -  Provide informed written consent&#xD;
&#xD;
          -  Willing to return to Mayo Clinic Rochester for follow-up&#xD;
&#xD;
          -  Willing to provide blood samples for correlative research purposes&#xD;
&#xD;
          -  Willingness to take BKM120 orally&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following:&#xD;
&#xD;
               -  Pregnant women&#xD;
&#xD;
               -  Nursing women&#xD;
&#xD;
               -  Women of childbearing potential who are unwilling to employ highly effective&#xD;
                  contraception during dosing with BKM120 and for 4 weeks after the final dose of&#xD;
                  treatment; NOTE: women of childbearing potential are defined as all women&#xD;
                  physiologically capable of becoming pregnant&#xD;
&#xD;
               -  Men of childbearing potential who are unwilling to employ highly effective&#xD;
                  contraception during dosing with BKM120 and for 16 weeks after the final dose of&#xD;
                  treatment and should not a father a child during this time; NOTE: men of&#xD;
                  childbearing potential are defined as all males physiologically capable of&#xD;
                  conceiving offspring&#xD;
&#xD;
                    -  NOTE: the highly effective contraception is defined as either:&#xD;
&#xD;
                         -  True abstinence: when this is in line with the preferred and usual&#xD;
                            lifestyle of the subject; periodic abstinence (e.g., calendar,&#xD;
                            ovulation, symptothermal, post-ovulation methods) and withdrawal are&#xD;
                            not acceptable methods of contraception&#xD;
&#xD;
                         -  Sterilization: have had surgical bilateral oophorectomy (with or&#xD;
                            without hysterectomy) or tubal ligation at least six weeks ago; in case&#xD;
                            of oophorectomy alone, only when the reproductive status of the woman&#xD;
                            has been confirmed by follow up hormone level assessment&#xD;
&#xD;
                         -  Male partner sterilization (with the appropriate post-vasectomy&#xD;
                            documentation of the absence of sperm in the ejaculate); for female&#xD;
                            subjects on the study, the vasectomized male partner should be the sole&#xD;
                            partner for that patient&#xD;
&#xD;
                         -  Use of a combination of any two of the following (a+b):&#xD;
&#xD;
                              1. Placement of an intrauterine device (IUD) or intrauterine system&#xD;
                                 (IUS)&#xD;
&#xD;
                              2. Barrier methods of contraception: condom or occlusive cap&#xD;
                                 (diaphragm or cervical/vault caps) with spermicidal&#xD;
                                 foam/gel/film/cream/vaginal suppository&#xD;
&#xD;
                         -  Oral contraception, injected or implanted hormonal methods are not&#xD;
                            allowed&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
&#xD;
          -  Average baseline of &gt;= 4 stools per day&#xD;
&#xD;
          -  Therapy with myelosuppressive chemotherapy or biologic therapy &lt; 21 days prior to&#xD;
             registration unless the patient has recovered from the nadir of the previous treatment&#xD;
             to a level that meets the inclusion eligibility criteria of this protocol&#xD;
&#xD;
          -  Patients who have received any continuous or intermittent small molecule therapeutics&#xD;
             (excluding monoclonal antibodies) =&lt; 5 effective half-lives prior to registration or&#xD;
             who have not recovered from side effects of such therapy&#xD;
&#xD;
          -  Received wide field radiotherapy =&lt; 28 days or limited field radiation for palliation&#xD;
             =&lt; 14 days prior to registration or who have not recovered from side effects of such&#xD;
             therapy&#xD;
&#xD;
          -  Receiving corticosteroids &gt; 10 mg of prednisone per day (or equivalent); NOTE:&#xD;
             patients may be receiving stable doses of corticosteroids with a maximum dose of 10 mg&#xD;
             of prednisone per day if they are being given for disorders other than lymphoma such&#xD;
             as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency, or asthma&#xD;
&#xD;
          -  Persistent toxicities &gt;= grade 2 from prior chemotherapy or biological therapy&#xD;
             regardless of interval since last treatment&#xD;
&#xD;
          -  Active cardiac disease including any of the following:&#xD;
&#xD;
               -  Left ventricular ejection fraction (LVEF) &lt; 45% as determined by multi gated&#xD;
                  acquisition (MUGA) scan or echocardiogram (ECHO)&#xD;
&#xD;
               -  Fridericia's corrected QT interval (QTcF) &gt; 450 msec on screening&#xD;
                  electrocardiogram (ECG) (using the QTcF formula)&#xD;
&#xD;
               -  Unstable angina pectoris; patients with unstable angina should have angina&#xD;
                  controlled before entering the study&#xD;
&#xD;
               -  Ventricular arrhythmias except for benign premature ventricular contractions&#xD;
&#xD;
               -  Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled&#xD;
                  with medication&#xD;
&#xD;
               -  Conduction abnormality requiring a pacemaker&#xD;
&#xD;
               -  Symptomatic pericarditis&#xD;
&#xD;
               -  Myocardial infraction within the last 6 months, documented by persistent elevated&#xD;
                  cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF&#xD;
                  function&#xD;
&#xD;
               -  History of documented congestive heart failure (New York Heart Association&#xD;
                  functional classification III-IV)&#xD;
&#xD;
               -  Documented cardiomyopathy&#xD;
&#xD;
          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy&#xD;
             considered investigational (utilized for a non-Food and Drug Administration&#xD;
             [FDA]-approved indication and in the context of a research investigation)&#xD;
&#xD;
          -  Known positivity for human immunodeficiency virus (HIV); note: baseline testing for&#xD;
             HIV is not required&#xD;
&#xD;
          -  Active hepatitis B or C with uncontrolled disease; note: a detailed assessment of&#xD;
             hepatitis B/C medical history and risk factors must be done at screening for all&#xD;
             patients; hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) ribonucleic&#xD;
             acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all&#xD;
             patients with a positive medical history based on risk factors and/or confirmation of&#xD;
             prior hepatitis B virus (HBV) infection&#xD;
&#xD;
          -  Other active malignancy requiring treatment that would interfere with the assessments&#xD;
             of response of the lymphoma to protocol treatment&#xD;
&#xD;
          -  Inability to swallow or impairment of gastrointestinal function or gastrointestinal&#xD;
             disease that may significantly alter the absorption of the drugs (e.g., ulcerative&#xD;
             disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small&#xD;
             bowel resection) that would preclude use of oral medications&#xD;
&#xD;
          -  Any severe and/or uncontrolled medical conditions such as diabetes, poor lung&#xD;
             function, or other conditions that, in the treating physician's opinion, could&#xD;
             adversely impact their ability to participate in the study&#xD;
&#xD;
          -  Patients who have received prior treatment with a P13K inhibitor; patients with prior&#xD;
             mammalian target of rapamycin (mTOR) inhibitor therapy are eligible&#xD;
&#xD;
          -  Using medications that have a strong risk of prolonging the QT interval or inducing&#xD;
             torsades de pointes&#xD;
&#xD;
          -  Major surgery =&lt; 14 days prior to registration or have not recovered from side effects&#xD;
             of such therapy&#xD;
&#xD;
          -  Currently being treated with drugs known to be moderate and strong inhibitors or&#xD;
             inducers of isoenzyme cytochrome P450, family 3, subfamily A, polypeptide 4/5&#xD;
             (CYP3A4/5), (please note that co-treatment with weak inhibitors of cytochrome P450,&#xD;
             family 3, subfamily A [CYP3A] is allowed)&#xD;
&#xD;
          -  Receiving certain fruits or herbal preparations/medications including, but are not&#xD;
             limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba,&#xD;
             dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng; fruits include the&#xD;
             CYP3A inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits; NOTE:&#xD;
             patients should stop using these fruits and herbal medications 7 days prior to first&#xD;
             dose of study drug&#xD;
&#xD;
          -  Primary central nervous system (CNS) lymphoma or active metastases to the CNS; NOTE:&#xD;
             active is defined as requiring therapy such as surgery, radiation, or chemotherapy =&lt;&#xD;
             28 days of study registration or ongoing corticosteroid therapy for CNS disease&#xD;
&#xD;
          -  The following mood disorders as judged by the Investigator or a psychiatrist, or as a&#xD;
             result of patient's mood assessment questionnaire:&#xD;
&#xD;
               -  Medically documented history of or active major depressive episode, bipolar&#xD;
                  disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of&#xD;
                  suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm&#xD;
                  to others)&#xD;
&#xD;
               -  &gt;= Common Terminology Criteria of Adverse Events (CTCAE) grade 3 anxiety&#xD;
&#xD;
               -  Meets the cut-off score of &gt;= 12 in the Patient Health Questionnaire (PHQ)-9 or a&#xD;
                  cut-off of &gt;= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale,&#xD;
                  respectively, or selects a positive response of &quot;1, 2, or 3&quot; to question number 9&#xD;
                  regarding potential for suicidal thoughts in the PHQ-9 (independent of the total&#xD;
                  score of the PHQ-9)&#xD;
&#xD;
          -  Treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim&#xD;
             [G-CSF], sargramostim [GM-CSF]) =&lt; 2 weeks prior to study registration; NOTE:&#xD;
             erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to study&#xD;
             registration, may be continued&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Witzig</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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/NCT01719250
org study id: MC1183
secondary id: NCI-2012-01582
secondary id: MC1183
secondary id: P30CA015083
nct id: NCT01719250
lead sponsor: 
collaborator: 
has dmc: No
This pilot clinical trial studies how well buparlisib works in treating patients with
      non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to
      previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth.
PRIMARY OBJECTIVES:

      I. To evaluate the clinical benefit rate (complete response [CR], partial response [PR] or
      standard disease [SD] >= 6 months) with BKM120 (buparlisib) in patients with relapsed or
      refractory lymphoma.

      SECONDARY OBJECTIVES:

      I. To evaluate overall response rate, overall survival, progression-free survival and
      duration of response.

      II. To describe the toxicities associated with BKM120 in lymphoma. III. To evaluate
      prognostic factors for aggressive lymphoma and whether there's a correlation with clinical
      benefit.

      TERTIARY OBJECTIVES:

      I. To assess serum cytokines before and after BKM120 therapy. II. To assess
      phosphatidylinositol 3-kinase (PI3K) pathway member expression on paraffin-embedded tumor
      samples pre-treatment.

      III. To assess on paired fresh tumor tissue obtained from consenting patients pre- and
      post-therapy the change in activation of PI3K pathway members.

      OUTLINE: Patients receive buparlisib orally (PO) once daily (QD) on days 1-28. Courses repeat
      every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 1 year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical benefit defined as a PR or CR as the objective status at any time or an objective status of SD for a duration of greater than 6 months from registration
time frame: From 6 months from registration up to 1 year
description: The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.
measure: Duration of response
time frame: From the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 1 year
description: If an adequate number of events are seen, the distribution of duration of response will be estimated using the method of Kaplan-Meier. Otherwise, duration of response will be summarized descriptively.
measure: Overall response rate estimated by the number of confirmed responses (PR or CR) observed in the trial divided by the total number of evaluable patients
time frame: Up to 1 year
description: Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
measure: Prognostic factors for aggressive lymphoma
time frame: Up to 1 year
description: Will be summarized and used to help characterize the types of patients accrued to this trial. These classifications will be correlated with clinical benefit using Fisher's exact or Wilcoxon rank sum tests.
measure: Progression-free survival time
time frame: Time from registration to progression or death due to any cause, assessed up to 1 year
description: Will be estimated using the method of Kaplan-Meier.
measure: Survival time
time frame: Time from registration to death due to any cause, assessed up to 1 year
description: Will be estimated using the method of Kaplan-Meier.
arm group label: Treatment (buparlisib)
arm group type: Experimental
description: Patients receive buparlisib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Buparlisib
description: Given PO
arm group label: Treatment (buparlisib)
other name: BKM120
other name: PI3K Inhibitor BKM120
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (buparlisib)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (buparlisib)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Witzig
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Recurrence