A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).

Key facts

Study ID

NCT01779791

Run by

Janssen Research & Development, LLC

People needed

110

Starts

2013-04-17

Expected to finish

2016-05-18

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation
• Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease)
• Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen
• At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma
• Eastern Cooperative Oncology Group performance status grade 0 or 1
• Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment
• Agrees to protocol-defined use of effective contraception
• Women of childbearing potential must have a negative serum or urine pregnancy test at screening

You may not qualify if…

• Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug
• Prior treatment with PCI-32765 or other Bruton's tyrosine kinase inhibitors (patients who progressed or became refractory while on treatment with PI3K inhibitors are excluded)
• Concurrent enrollment in another therapeutic investigational clinical treatment study
• Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed)
• Known central nervous system lymphoma
• History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease)
• History of stroke or intracranial hemorrhage within 6 months prior to enrollment
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists
• Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics
• Women who are pregnant or breastfeeding
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue risk

Where it is running

• Study site — Stanford, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Westwood, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Greenville, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Seattle, Washington, United States
• Study site — Adelaide, Australia
• Study site — Concord, Australia
• Study site — Melbourne, Australia
• Study site — Milton, Australia
• Study site — Prahran, Australia
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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