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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)

Phase 2
18 Years
Open (Enrolling)
Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory/Relapsed Chronic Lymphocytic Leukemia

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Trial Information

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.

Inclusion Criteria:

- Confirmed diagnosis of relapsed/refractory CLL/SLL who require treatment and have
failed at least one prior therapy.

- Patients must have available results of interphase cytogenetics CLL fluorescent in
situ hybridization (FISH) panel; the cytogenetic analysis must be done prior to
starting therapy but after any recent therapy

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Life expectancy greater than 2 months

- Bilirubin =< 1.5 X the institutional upper limit of normal unless due to Gilbert's
disease or disease related to Aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) =< 2.5 X the institutional upper limit of normal unless
disease related

- Creatinine =< 1.5 X the institutional upper limit of normal unless disease related

- Absolute neutrophil count (ANC) >= 0.75 X 10^9/L

- Platelet count >= 30 X 10^9/L

- Agree to use contraception during the study and for 30 days after the last dose of
study drug if sexually active and able to bear children

- Ability to understand and the willingness to sign a written informed consent document

- Patients with uncontrolled or active infection requiring antibiotic therapy; patients
with controlled infections who are receiving extended antibiotics or prophylactic
therapy are not excluded

Exclusion Criteria:

- Patients who have had chemotherapy, radiotherapy or immunotherapy within 4 weeks
prior to the first dose of study drug (corticosteroids for disease-related symptoms
allowed but doses equivalent to > 20 mg prednisone orally per day require 1 week
washout before study drug administration or steroid dose must be equal to =< 20 mg
prednisone orally daily)

- Patients who have not recovered from adverse events of >= grade 3 toxicity due to
agents administered more than 4 weeks ago

- Receiving any other investigational agents

- Previously randomized to any PCI-32765 clinical trial

- Known secondary malignancy that limits survival to less than two years

- Patients with malabsorption syndrome, disease significantly affecting
gastrointestinal function, or resection of the stomach or small bowel or ulcerative
colitis, symptomatic inflammatory bowel disease, or partial or complete bowel

- Patients requiring anti-coagulation with warfarin or heparin products including low
molecular weight heparin (LMWH)

- Patients requiring treatment with a strong cytochrome P450 3A4/5 (CYP3A4/5) and/or
cytochrome P450 2D6 (CYP2D6) inhibitor

- Patients with a life-threatening illness, medical condition or organ system
dysfunction which, in the investigator's opinion, could compromise the subject's
safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study
outcomes at undue risk

- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
congestive heart failure, or myocardial infarction within 6 months of screening, or
any Class 3 or 4 cardiac disease as defined by the New York Heart Association
Functional Classification

- Active central nervous system (CNS) involvement by lymphoma

- Pregnant or women who are breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the 2 year progression-free survival (PFS) of single agent PCI-32765 in patients with relapsed and refractory CLL.

Outcome Description:

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.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Kami Maddocks-Christianson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Prolymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory/Relapsed Chronic Lymphocytic Leukemia
  • Bruton's Tyrosine Kinase
  • CLL
  • SLL
  • B-PLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Lymphoma
  • Leukemia, Prolymphocytic, B-Cell



Ohio State University Medical Center Columbus, Ohio  43210