A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This trial is active, not recruiting.
|Conditions||relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma|
|Collaborator||Janssen Research & Development, LLC|
|Start date||June 2012|
|End date||June 2017|
|Trial size||391 participants|
|Trial identifier||NCT01578707, 2012-000694-23, PCYC-1112-CA|
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)
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
PFS (Progression Free Survival)
time frame: Analysis will be conducted after observing approximately 117 PFS events
OS (Overall Survival)
time frame: 5 years
time frame: 2 years
Improvement of disease-related symptoms (fatigue, night sweats, and splenomegaly).
time frame: 2 years
Male or female participants at least 18 years old.
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.
|Official title||A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|
|Description||Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Patients randomized to the ofatumumab arm who experience disease progression (PD) may be considered to receive next subsequent therapy with ibrutinib.|
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