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

Trial Source

There is no location for this trial

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Health Conditions
  • Mantle Cell Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Ibrutinib

Study Arm Groups : Ibrutinib

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
London
Plymouth
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Belgium, France, Israel, Poland, Russian Federation, Spain, United Kingdom
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
EudraCT Number
Not available for this trial
Funder(s)
  • Pharmacyclics
Other Study ID Numbers
CR100847
Sponsor(s)
Janssen Research & Development, LLC
Key Dates

Recruitment Start Date

Aug 2012

Recruitment End Date

Apr 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

14 May 2012

Last Updated

06 Feb 2015