A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

• Status: Completed
• Trial end date: 2017-08-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Pharmacyclics LLC.
• Treatments: Rituximab

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)