A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

Not Recruiting

Trial ID: NCT01776840


The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Official Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Stanford Investigator(s)

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology


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:

   - 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

   - 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

   - 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


drug: Bendamustine

drug: Rituximab

drug: Ibrutinib

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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