A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Ibrutinib
Intervention description: Up to 6 cycles (total of 8 doses administered by intravenous infusion): 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); and 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).; 420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic lymphocytic leukemia; Small lymphocytic lymphoma; Relapsed or refractory chronic lymphocytic leukemia; Relapsed or refractory small lymphocytic lymphoma; Ibrutinib; PCI-32765; Bruton's tyrosine kinase inhibitor; Rituximab; Asia Pacific region participants

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus
      rituximab in adult Asia Pacific region patients with relapsed or refractory chronic
      lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group performance status of 0-1

          -  Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that
             meets protocol-defined criteria

          -  Laboratory values within protocol-defined parameters

          -  Active disease meeting International Workshop on Chronic Lymphocytic Leukemia 2008
             criteria

          -  Received at least 1 prior therapy for CLL/SLL and not appropriate for treatment or
             retreatment with purine analog-based therapy

          -  Measurable nodal disease by computed tomography

          -  Female subjects of childbearing potential must have a negative serum or urine
             pregnancy test at Screening and agree to use highly effective methods of contraception
             during the study and for 90 days following the last dose with ibrutinib or 12 months
             following the last dose of rituximab

        Exclusion Criteria:

          -  Central nervous system lymphoma or leukemia

          -  Prolymphocytic leukemia or history of or currently suspected Richter's transformation

          -  Refractory to prior rituximab-based therapy

          -  Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or
             investigational drug within 30 days prior to first dose of study drug

          -  Corticosteroid use >20 mg within 1 week prior to first dose of study drug

          -  Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose of
             study drug

          -  Prior autologous transplant within 6 months prior to first dose of study drug

          -  Prior allogeneic stem cell transplant

          -  Major surgery within 4 weeks prior to first dose of study drug

          -  History of prior malignancy according to protocol-defined criteria

          -  Currently active clinically significant cardiovascular disease within 6 months prior
             to first dose with study drug

          -  Uncontrolled active systemic fungal, bacterial, viral, or other ongoing anti-infective
             treatment administered intravenously

          -  History of human immunodeficiency virus or active infection with hepatitis B or C

          -  History of stroke or intracranial hemorrhage within 6 months prior to random
             assignment

          -  Pregnant or lactating women

          -  Current life-threatening illness, medical condition, or organ system dysfunction
             which, in the investigator's opinion, could compromise the patient's safety, or put
             the study at risk

          -  Requires or receiving anticoagulation with warfarin or equivalent Vitamin K
             antagonists

          -  Requires treatment with a strong CYP3A4/5 inhibitor

          -  Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura
             (ITP), defined as declining hemoglobin or platelet count secondary to autoimmune
             destruction within the screening period or requirement for high doses of steroids
             (greater than [>]20 milligram [mg] daily of prednisone daily or equivalent)