Clinical Trial: PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evaluated.

Detailed Summary: 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.
Sponsor: Kami Maddocks

Current Primary Outcome: Determine the 2 year progression-free survival (PFS) of single agent PCI-32765 in patients with relapsed and refractory CLL. [ Time Frame: up to 2 years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate (ORR), duration of response (DOR) overall survival (OS),assessed using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) working group guidelines [ Time Frame: up to 2 years ]
    Time from date at which the patient's objective status is first noted to be a response to the date that progression or death is documented (if one has occurred) or to the date of last follow-up (for those patients who have not progressed) up to 2 years
  • Frequency, severity and relatedness of adverse events, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 30 days post last day of treatment ]
  • Pharmacodynamic, cytokine, primary/secondary resistance studies of ibrutinib, and baseline profiling of tumor cells [ Time Frame: Pre-dose on course 1 day 1 and 2 hours post-dose course 1 day 1; pre-dose day 2 and day 8 of course 1; pre-dose on day 1 of courses 2 and 3 and then every 3 months thereafter for 1 year ]
  • Patient reported emotional distress and health related quality of life [ Time Frame: Up to 2 years ]
  • Decrease in immune suppression of CLL cells [ Time Frame: up to 3 months ]
  • Effectiveness of ibrutinib bridging patients to allogeneic stem cell transplant and outcome of patients following this intervention [ Time Frame: Up to 2 years ]
    Transplant is a positive clinical outcome, those who go to transplant prior to two years will be considered a treatment success and included in the numerator of this proportion.


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: April 23, 2012
Date Started: May 21, 2012
Date Completion: December 31, 2019
Last Updated: March 20, 2017
Last Verified: March 2017