Follicular Lymphoma MedDRA version: 18.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: Ibrutinib
Product Code: JNJ-54179060
Pharmaceutical Form: Capsule
INN or Proposed INN: Ibrutinib
CAS Number: 936563-96-1
Current Sponsor code: JNJ-54179060
Other descriptive name: IBRUT
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 P13K 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the ORR of ibrutinib, as assessed by the Independent Review Committee (IRC), in subjects with chemoimmunotherapy-resistant FL;Secondary Objective: The secondary objectives are to: ? Evaluate the duration of response ? Evaluate the safety of ibrutinib;Primary end point(s): Overall response rate ;Timepoint(s) of evaluation of this end point: up to 2 years after the last patient is enrolled | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response ;Timepoint(s) of evaluation of this end point: Time frame = every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled) | — |
Countries
Australia, Belgium, France, Germany, Italy, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed