A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy | Not Recruiting
A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy
Health Conditions
  • Mantle Cell Lymphoma
Not Recruiting
Recruitment Status
NCT01599949
Primary Trial ID Number
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.
Primary Outcome Measures
  • Overall response rate; 1 year after the last patient is enrolled
Secondary Outcome Measures
  • 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; Maximum observed plasma concentration of ibrutinib; Up to Cycle 2, Day 21; Minimum observed plasma concentration of ibrutinib; Up to Cycle 2, Day 21; Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib; Up to Cycle 2, Day 21; The number of participants affected by an adverse event; Up to 30 days after the last dose of study medication; Overall response rate; 1 year after the last patient is enrolled and 2 years after the last patient is enrolled
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Belgium; France; Israel; Poland; Russian Federation; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; 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.; [Ibrutinib]
Design Details
Sorry, this information is not available
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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
Secondary Trial Identifying Number
PCI-32765MCL2001; 2012-000711-88
Website
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Study Funded By
Janssen Research & Development, LLC
Funder Type
Sorry, this information is not available
Study Sponsored By
Janssen Research & Development, LLC
Study Also Sponsored By
Pharmacyclics
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 May 2012

Last Updated

06 Feb 2015

Date Record Refreshed on UKCTG

01 Aug 2015