A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2018-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborator: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria:

• ECOG performance status of 0-1.

• Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.

• Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.

• Must have received at least one prior therapy for CLL/SLL.

• Considered not appropriate for treatment or retreatment with purine analog based therapy.

• Measurable nodal disease by CT.

• Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.

Exclusion Criteria:

• Known CNS lymphoma or leukemia.

• No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.

• Any history of Richter's transformation or prolymphocytic leukemia.

• Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).

• Prior exposure to ofatumumab or to ibrutinib.

• Prior autologous transplant within 6 months prior to first dose of study drug.

• Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.

• History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.

• Serologic status reflecting active hepatitis B or C infection.

• Unable to swallow capsules or disease significantly affecting gastrointestinal function.

• Uncontrolled active systemic fungal, bacterial, viral, or other infection.

• History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.

• Requires anticoagulation with warfarin.