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A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
Not Recruiting
Trial ID: NCT01779791
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
Stanford Investigator(s)
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Ash A. Alizadeh, MD/PhD
Moghadam Family Professor
Eligibility
Inclusion Criteria:
- 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:
- 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
Intervention(s):
drug: PCI-32765 (Ibrutinib)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061