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NCT01589302Active, not recruitingPhase 2

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

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)

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
154 (actual)
First submitted
23 Apr 2012
Start date
21 May 2012
Primary completion date
28 Jul 2016
Lead sponsor
Kami Maddocks, MD
NCT number
NCT01589302

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 154
  • From 21 May 2012 to the primary completion date, 28 Jul 2016
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Receiving any other investigational agents
  • Previously randomized to any PCI-32765 clinical trial
  • Patients requiring treatment with a strong cytochrome P450 3A4/5 (CYP3A4/5) and/or cytochrome P450 2D6 (CYP2D6) inhibitor

Other illness

  • 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 obstruction
  • Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
  • 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

Other

  • Patients who have not recovered from adverse events of \>= grade 3 toxicity due to agents administered more than 4 weeks ago
  • Patients requiring anti-coagulation with warfarin or other Vitamin K antagonists or heparin products including low molecular weight heparin (LMWH)
  • Active central nervous system (CNS) involvement by lymphoma
  • Pregnant or women who are breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohio State University Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.