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

Trial ID or NCT#

NCT01779791

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
Exclusion Criteria:
  1. * 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

Investigator(s)

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD
Medical oncologist, Lymphoma specialist, Cancer geneticist
Moghadam Family Professor
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

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Contact

CCTO
650-498-7061