Mantel cell lymphome or Non-Hodgekin lymphoma
Conditions
Interventions
One group of patients will receive daily capsules of Ibrutinib, while the other
group of patients will receive daily placebo capsules.
Sponsors
Janssen-Cilag
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central laboratory: diagnosis must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5) and CD5 or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR), - Clinical Stage II, III, or IV by Ann Arbor Classification, - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma, - No prior therapies for MCL, - Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1, - Hematology and biochemical laboratory values within protocol-defined limits, - Agrees to protocol-defined use of effective contraception, - Negative blood or urine pregnancy test at screening
Exclusion criteria
Exclusion criteria: - Major surgery within 4 weeks of random assignment, - Known central nervous system lymphoma, - Diagnosed or treated for malignancy other than MCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease, - Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant, - History of stroke or intracranial hemorrhage within 6 months prior to random assignment, - Requires anticoagulation with warfarin or equivalent vitamin K antagonists, - Requires treatment with strong CYP3A 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, - Vaccinated with live, attenuated vaccines within 4 weeks of random assignment, - Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics, - 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 ibrutinib capsules, or put the study outcomes at undue risk
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: • To evaluate overall survival • To evaluate the CR rate and overall response rate (CR+PR) • To evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) • To evaluate the minimal residual disease (MRD) negative rate • To evaluate duration of response • To evaluate time-to-next treatment (TTNT) • To evaluate the safety of ibrutinib when combined with BR • To characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Objective The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older. | — |
Countries
Netherlands
Outcome results
None listed