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

NCT01599949 | Completed Phase 2

• 3 other identifiers: CR100847PCI-32765MCL20012012-000711-88
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 56

Brief Summary

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.

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma; Ibrutinib; Bruton's tyrosine kinase inhibitor; Rituximab; Bortezomib

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  1 year after the last patient is enrolled

Secondary Outcomes (10)

• Overall survival rate

  1 year after the last patient is enrolled and 2 years after the last patient is enrolled

• Progression-free survival rate

  1 year after the last patient is enrolled and 2 years after the last patient is enrolled

• Mean change from baseline in the Lym subscale

  1 year after the last patient is enrolled and 2 years after the last patient is enrolled

• Mean change from baseline in the EQ-5D-5L index

  1 year after the last patient is enrolled and 2 years after the last patient is enrolled

• Mean plasma concentrations of ibrutinib

  Up to Cycle 2, Day 21

Study Arms (1)

Ibrutinib

EXPERIMENTAL

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.

Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Pharmacyclics LLC.: collaborator

Study Sites (56)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Norwalk, Connecticut, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Peoria, Illinois, United States

Location

Unknown Facility

Goshen, Indiana, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Sioux City, Iowa, United States

Location

Unknown Facility

Westwood, Kansas, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Metairie, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Jefferson City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Watertown, South Dakota, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Morgantown, West Virginia, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Grenoble, France

Location

Unknown Facility

Mulhouse, France

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Pessac, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Afula, Israel

Location

Unknown Facility

Beer Yaakov, Israel

Location

Unknown Facility

Hadera, Israel

Location

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Nahariya, Israel

Location

Unknown Facility

Petah Tikva, Israel

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Chorzów, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

San Juan, Puerto Rico

Location

Unknown Facility

Nizhny Novgorod, Russia

Location

Unknown Facility

Rostov-on-Don, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Salamanca, Spain

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Related Links

• 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

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

PR (1); RU (3); FR (5); PL (2); US (32); ES (2); IL (7); GB (2); BE (2)