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

NCT ID: NCT01599949

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-05-31

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.

Detailed Description

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. An interim analysis of the pharmacokinetic data will occur approximately 3 months after the scheduled pharmacokinetic sampling in Cycles 1 and 2 has been completed. Data will be analyzed 1 year after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ibrutinib

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: 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.

Interventions

Ibrutinib

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

La Jolla, California, United States

Los Angeles, California, United States

Stanford, California, United States

Norwalk, Connecticut, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Peoria, Illinois, United States

Goshen, Indiana, United States

Iowa City, Iowa, United States

Sioux City, Iowa, United States

Westwood, Kansas, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Metairie, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Jefferson City, Missouri, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Hackensack, New Jersey, United States

New York, New York, United States

Syracuse, New York, United States

Watertown, South Dakota, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Burlington, Vermont, United States

Charlottesville, Virginia, United States

Morgantown, West Virginia, United States

Madison, Wisconsin, United States

Bruges, , Belgium

Ghent, , Belgium

Grenoble, , France

Mulhouse, , France

Nantes, , France

Pessac, , France

Vandœuvre-lès-Nancy, , France

Afula, , Israel

Beer Yaakov, , Israel

Hadera, , Israel

Haifa, , Israel

Nahariya, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Chorzów, , Poland

Lodz, , Poland

San Juan, , Puerto Rico

Nizhny Novgorod, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Barcelona, , Spain

Salamanca, , Spain

London, , United Kingdom

Plymouth, , United Kingdom

Countries

United States; Belgium; France; Israel; Poland; Puerto Rico; Russia; Spain; United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3515&filename=CR100847_CSR.pdf

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

Other Identifiers

PCI-32765MCL2001

Identifier Type: OTHER

Identifier Source: secondary_id

2012-000711-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100847

Identifier Type: -

Identifier Source: org_study_id