A Phase 2 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765(Ibrutinib), in Relapsed and Refractory Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and B-cell Prolymphocytic Leukemia (B-PLL)
This is a clinical trial, a type of research study, involving treatment with an
investigational (experimental) drug called PCI-32765 (Ibrutinib), a "kinase inhibitor".
"Kinases" are proteins that are inside of cells and help them to live and grow. The specific
kinase inhibited or blocked by this study drug is believed to help blood cancer cells grow
and live. By inhibiting or "blocking" the activity of this kinase, it is possible that the
study drug may be able to kill the cancer cells or stop them from growing. This study will
involve treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic
lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL) that has not responded to or has
relapsed after standard treatment. This trial is studying how effective PCI-32765 is at
treating CLL, SLL, or B-PLL and all the effects, good and/or bad, treatment with this drug
has on patients and their cancers.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the 2 year progression-free survival (PFS) of single agent PCI-32765 in patients with relapsed and refractory CLL.
We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort.
up to 2 years
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|