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Health Condition(s) or Problem
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Mantle Cell Lymphoma
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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
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Primary aim
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Overall response rate
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Secondary Aim
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Overall survival rate; 6 months after the last patient is enrolled and 2 years after the last patient is enrolled; No; Progression-free survival rate; 6 months after the last patient is enrolled and 2 years after the last patient is enrolled; No; Mean change from baseline in the Lym subscale; 6 months after the last patient is enrolled and 2 years after the last patient is enrolled; No; Mean change from baseline in the EQ-5D-5L index; 6 months after the last patient is enrolled and 2 years after the last patient is enrolled; No; Mean plasma concentrations of ibrutinib; Up to Cycle 2, Day 21; No; Maximum observed plasma concentration of ibrutinib; Up to Cycle 2, Day 21; No; Minimum observed plasma concentration of ibrutinib; Up to Cycle 2, Day 21; No; Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib; Up to Cycle 2, Day 21; No; The number of participants affected by an adverse event; Up to 30 days after the last dose of study medication; Yes; Overall response rate; 6 months after the last patient is enrolled and 2 years after the last patient is enrolled; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://pam.sylogent.com/cr/CR100847
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London, Plymouth
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