chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma MedDRA version: 21.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classifi
Conditions
Interventions
Trade Name: IMBRUVICA®
Product Name: Ibrutinib
Product Code: JNJ-54179060
Pharmaceutical Form: Capsule
INN or Proposed INN: Ibrutinib
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765. At study entry, participants must be actively receiving treatment with single-agent PCI-32765. OR - Subjects must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and subjects with less than 6 months will be required to have more frequent initial safety assessments (see Time and Events Table 2) - Agrees to protocol-defined use of effective contraception - Negative blood or urine pregnancy test at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: - Requires anticoagulation with warfarin or equivalent vitamin K antagonists - Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor - Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with PCI-32765, and who continue to benefit from PCI-32765 treatment.;Secondary Objective: Not applicable;Primary end point(s): Number of participants affected by an adverse event;Timepoint(s) of evaluation of this end point: Time frame = Up to 30 days after the last dose of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of participants with change in disease status ; Timepoint(s) of evaluation of this end point: Time frame = Up to the end-of-treatment visit (up to 30 days after the last dose of study medication) | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed