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

Not Recruiting

Trial ID: NCT01599949

Purpose

The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

Official Title

A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

Eligibility


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 1 prior 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

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 or equivalent vitamin K antagonists

   - Requires treatment with strong CYP3A4/5 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 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

Intervention(s):

drug: Ibrutinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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