<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/NCT04434196</url>
  </required_header>
  <id_info>
    <org_study_id>CC-99282-CLL-001</org_study_id>
    <secondary_id>U1111-1251-4261</secondary_id>
    <secondary_id>2019-003228-18</secondary_id>
    <nct_id>NCT04434196</nct_id>
  </id_info>
  <brief_title>A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</brief_title>
  <official_title>A Phase 1B, Multicenter, Open-label Study to Determine the Safety, Pharmacokinetics and Preliminary Efficacy of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</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>
      CC-99282-CLL-001 study is a Phase IB dose escalation and expansion clinical study of CC-99282&#xD;
      administered in combination with Obinutuzumab in subjects with relapsed or refractory Chronic&#xD;
      Lymphocytic Leukemia/Small Lymphocytic Lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible subjects must be relapsed or refractory to at least 2 prior lines of therapy,&#xD;
      one of which must have included an inhibitor of B-cell receptor signaling (approved Bruton's&#xD;
      tyrosine kinase inhibitor [BTKi] or Phosphoinositide 3-kinase inhibitor [PI3Ki]) or&#xD;
      venetoclax. The dose escalation (Part A) will evaluate the safety, tolerability, and PK of&#xD;
      escalating doses of CC-99282 given in combination with intravenous obinutuzumab to determine&#xD;
      the MTD and RP2D of CC-99282 when given in combination with obinutuzumab. The dose expansion&#xD;
      (Part B) may occur at the MTD established in the dose escalation phase, or at an alternative&#xD;
      tolerable dosing schedule, based on review of safety, PK and PD data from Part A.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 21, 2020</start_date>
  <completion_date type="Anticipated">May 13, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Limiting Toxicity (DLT)</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Number of subjects with a DLT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD)</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days</time_frame>
    <description>The highest dose of CC-99282 in combination with obinutuzumab associated with acceptable safety and tolerability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>From first subjects first visit until 28 days after last subject discontinued study treatment</time_frame>
    <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Cmax</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - AUC</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Area under the plasma concentration-time curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Tmax</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Time to Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - T-HALF</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Terminal-phase elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - CLT/F</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Apparent total clearance of the drug from plasma after oral administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Vz/F</measure>
    <time_frame>Up to Cycle 2 Day 14 (each cycle is 28 days)</time_frame>
    <description>Apparent volume of distribution during terminal phase after non-intravenous administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>Sum of complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), partial response (PR), partial response with lymphocytosis (PRL) determined by iwCLL criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>Time from first documentation of response (≥ PR) to the first documentation of PD or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>Time from first dose of CC-99282 to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response with incomplete marrow recovery (CRi)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>As assessed by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nodular partial response (nPR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>As assessed by iwCL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial response (PR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>As assessed by iwC and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial response with lymphocytosis (PRL)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>As assessed by iwCLL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <arm_group>
    <arm_group_label>CC-99282 + obinutuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating doses of CC-99282 administered orally once daily on intermittent schedules with obinutuzumab IV infusion 1000 mg up to 2 years in Part A. CC-99282 administered orally once daily at MTD or alternative tolerating dosing schedule with obinutuzumab IV infusion 1000 mg up to 2 years in Part B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-99282</intervention_name>
    <description>CC-99282</description>
    <arm_group_label>CC-99282 + obinutuzumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Obinutuzumab</description>
    <arm_group_label>CC-99282 + obinutuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is ≥18 years of age&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.&#xD;
&#xD;
          3. Must have a documented diagnosis of CLL/SLL requiring treatment (IwCLL Guidelines for&#xD;
             the Diagnosis and Treatment of CLL). In addition presence of clinically measurable&#xD;
             disease determined by at least one of the factors listed:&#xD;
&#xD;
               -  nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in&#xD;
                  longest perpendicular dimension (LPD), or&#xD;
&#xD;
               -  spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum&#xD;
                  of 2 cm enlargement, or&#xD;
&#xD;
               -  liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or&#xD;
&#xD;
               -  peripheral blood B lymphocyte count &gt; 5000/uL&#xD;
&#xD;
          4. All eligible subjects must be relapsed after or be refractory to &gt;2 prior lines of&#xD;
             therapy one of which must have included an approved BTK inhibitor.&#xD;
&#xD;
          5. Must meet the following laboratory parameters:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3 or ≥ 1000 cells/mm^3 if&#xD;
                  secondary to bone marrow involvement by disease, without growth factor support&#xD;
                  for 7 days (14 days if pegfilgastrim).&#xD;
&#xD;
               2. Platelet count ≥ 75,000 cells/mm^3 (100 x 10^9/L) or ≥ 50,000 cells/mm^3 (50 x&#xD;
                  10^9/L) if secondary to bone marrow involvement by disease, without transfusion&#xD;
                  for 7 days.&#xD;
&#xD;
               3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) &lt; 3.0&#xD;
                  x upper limit of normal (ULN).&#xD;
&#xD;
               4. Serum bilirubin &lt; 1.5 x ULN unless due to Gilbert's syndrome.&#xD;
&#xD;
               5. Calculated creatinine clearance of ≥ 60 ml/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of any significant medical condition, laboratory abnormality, or psychiatric&#xD;
             illness that would prevent the subject from participating in the study.&#xD;
&#xD;
          2. Prior allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of&#xD;
             signing the ICF. Subjects who received allogeneic SCT ≥ 12 months before signing the&#xD;
             ICF may be eligible provided there is no ongoing graft-versus-host disease and no&#xD;
             ongoing immune suppression therapy.&#xD;
&#xD;
          3. Subject has received prior CAR-T or other T-cell targeting treatment (approved or&#xD;
             investigational) ≤ 4 weeks prior to starting CC-99282.&#xD;
&#xD;
          4. Subject has received prior therapy with CRBN-modulating drug (eg, lenalidomide,&#xD;
             avadomide/CC-122, pomalidomide) ≤ 4 weeks prior to starting CC-99282.&#xD;
&#xD;
          5. History of second malignancies with life expectancy of ≤ 2 years or requirement of&#xD;
             therapy that would confound study results.&#xD;
&#xD;
          6. Peripheral neuropathy ≥ Grade 2.&#xD;
&#xD;
          7. History of hypersensitivity to lenalidomide, pomalidomide, thalidomide.&#xD;
&#xD;
          8. Impaired cardiac function or clinically significant cardiac disease.&#xD;
&#xD;
          9. Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.&#xD;
&#xD;
         10. Active disease transformation (ie, Richter's Syndrome)&#xD;
&#xD;
         11. Uncontrolled/active autoimmune hemolytic anemia or thrombocytopenia&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 106</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 104</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 101</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97201-3098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 107</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 403</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 401</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 402</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 201</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 202</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 302</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 306</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 301</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 304</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 303</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 305</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>CC-99282</keyword>
  <keyword>Obinutuzumab</keyword>
  <keyword>Relapsed</keyword>
  <keyword>Refractory</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>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obinutuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link:&#xD;
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>See Plan Description</ipd_time_frame>
    <ipd_access_criteria>See Plan Description</ipd_access_criteria>
    <ipd_url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_url>
  </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/NCT04434196
org study id: CC-99282-CLL-001
secondary id: U1111-1251-4261
secondary id: 2019-003228-18
nct id: NCT04434196
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
CC-99282-CLL-001 study is a Phase IB dose escalation and expansion clinical study of CC-99282
      administered in combination with Obinutuzumab in subjects with relapsed or refractory Chronic
      Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
All eligible subjects must be relapsed or refractory to at least 2 prior lines of therapy,
      one of which must have included an inhibitor of B-cell receptor signaling (approved Bruton's
      tyrosine kinase inhibitor [BTKi] or Phosphoinositide 3-kinase inhibitor [PI3Ki]) or
      venetoclax. The dose escalation (Part A) will evaluate the safety, tolerability, and PK of
      escalating doses of CC-99282 given in combination with intravenous obinutuzumab to determine
      the MTD and RP2D of CC-99282 when given in combination with obinutuzumab. The dose expansion
      (Part B) may occur at the MTD established in the dose escalation phase, or at an alternative
      tolerable dosing schedule, based on review of safety, PK and PD data from Part A.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Limiting Toxicity (DLT)
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Number of subjects with a DLT
measure: Maximum tolerated dose (MTD)
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days
description: The highest dose of CC-99282 in combination with obinutuzumab associated with acceptable safety and tolerability
measure: Adverse Events (AEs)
time frame: From first subjects first visit until 28 days after last subject discontinued study treatment
description: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
measure: Pharmacokinetics - Cmax
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Maximum observed plasma concentration
measure: Pharmacokinetics - AUC
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Area under the plasma concentration-time curve
measure: Pharmacokinetics - Tmax
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Time to Cmax
measure: Pharmacokinetics - T-HALF
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Terminal-phase elimination half-life
measure: Pharmacokinetics - CLT/F
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Apparent total clearance of the drug from plasma after oral administration
measure: Pharmacokinetics - Vz/F
time frame: Up to Cycle 2 Day 14 (each cycle is 28 days)
description: Apparent volume of distribution during terminal phase after non-intravenous administration
measure: Objective response rate (ORR)
time frame: Up to approximately 3 years
description: Sum of complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), partial response (PR), partial response with lymphocytosis (PRL) determined by iwCLL criteria
measure: Duration of response (DoR)
time frame: Up to approximately 3 years
description: Time from first documentation of response (≥ PR) to the first documentation of PD or death
measure: Progression free survival
time frame: Up to approximately 3 years
description: Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause
measure: Overall survival
time frame: Up to approximately 3 years
description: Time from first dose of CC-99282 to death from any cause
measure: Complete response with incomplete marrow recovery (CRi)
time frame: Up to approximately 3 years
description: As assessed by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
measure: Nodular partial response (nPR)
time frame: Up to approximately 3 years
description: As assessed by iwCL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
measure: Partial response (PR)
time frame: Up to approximately 3 years
description: As assessed by iwC and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
measure: Partial response with lymphocytosis (PRL)
time frame: Up to approximately 3 years
description: As assessed by iwCLL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
arm group label: CC-99282 + obinutuzumab
arm group type: Experimental
description: Escalating doses of CC-99282 administered orally once daily on intermittent schedules with obinutuzumab IV infusion 1000 mg up to 2 years in Part A. CC-99282 administered orally once daily at MTD or alternative tolerating dosing schedule with obinutuzumab IV infusion 1000 mg up to 2 years in Part B.
intervention type: Drug
intervention name: CC-99282
description: CC-99282
arm group label: CC-99282 + obinutuzumab
intervention type: Drug
intervention name: Obinutuzumab
description: Obinutuzumab
arm group label: CC-99282 + obinutuzumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Austria
country: Canada
country: Spain
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Lymphoma, Non-Hodgkin
mesh term: Obinutuzumab
sharing ipd: Yes
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: See Plan Description
ipd access criteria: See Plan Description
ipd url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html