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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

Phase 2
18 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

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

This is a single-arm (all patients will receive the study drug) study to evaluate the
efficacy and safety of ibrutinib in patients with mantle cell lymphoma (MCL) who have
received at least 1 rituximab-containing chemotherapy regimen and who progressed after
bortezomib therapy. Approximately 110 eligible patients will be enrolled. During the
treatment phase, patients will receive 560 mg of ibrutinib by mouth once daily continuously
until disease progression, unacceptable toxicity, or study end, whichever occurs first.
Treatment will be continuous (without interruption) and self-administered at home. Doses can
be held or reduced based on the severity of and the recovery from side effects of the study
drug. The sponsor will ensure that patients benefiting from treatment with ibrutinib will be
able to continue treatment after the end of the study. Data will be collected on disease
response to the treatment, on progression-free survival, overall survival, and subsequent
anti-MCL therapies. Serial pharmacokinetic (study of what the body does to a drug) samples
will be collected as detailed in the protocol. Safety will be monitored throughout the
study. Data will be analyzed 6 months after the last patient is enrolled for the primary
analysis and 2 years after last patient is enrolled for the final follow-up.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

6 months after the last patient is enrolled

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

March 2015

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Ibrutinib
  • Bruton's tyrosine kinase inhibitor
  • Rituximab
  • Bortezomib
  • Lymphoma
  • Lymphoma, Mantle-Cell



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