A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress after Bortezomib Therapy.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

- Diagnosis of confirmed mantle cell lymphoma (MCL) with at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.
- Must have received at least 1prior rituximab-containing chemotherapy regimen, but no more than 5 prior regimens.
- Must have received at least 2 cycles of bortezomib therapy (single-agent or in combination) and have documented progressive
disease during or after bortezomib therapy
- Eastern Cooperative Oncology Group performance status score 0, 1, or 2.
- Hematology and biochemical values within protocol-defined parameters.
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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

- Prior chemotherapy within 3 weeks, nitrosoureas within 6 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 the first dose of study drug
- Prior treatment with ibrutinib or other Bruton´s tyrosine kinase inhibitors.
- More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval.
- 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 the first dose of study drug and felt to be at low risk for recurrence by the treating physician, 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 the first dose of study drug.
- Requires anticoagulation with warfarin.
- Requires treatment with strong CYP3A4/5 or CYP2D6 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 or active infection with hepatitis C virus or hepatitis B virus or any
uncontrolled active systemic infection.
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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