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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kami Maddocks

Criteria

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 obstruction

• Patients requiring anti-coagulation with warfarin or other Vitamin K antagonists or heparin products including low molecular weight heparin (LMWH)

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

• 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