Small Lymphocytic Lymphoma Clinical Trial
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
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)
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 may be considered to receive next subsequent
therapy with ibrutinib.
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