A Long-term Extension Study of PCI-32765 (Ibrutinib)
- Conditions
- chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, Waldenstrom’s macroglobulinemia, chronic graft versus host diseaseMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851MedDRA version: 24.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10054693Term: Von Waldenstrom macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004225-24-BE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 700
- Participants must be currently participating in a ibrutinib clinical study considered completed and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib
OR
- Subjects must have participated in a ibrutinib 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 ibrutinib 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to collect long-term safety and efficacy data for subjects treated with ibrutinib and to provide ongoing access to ibrutinib for subjects who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib 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 Outcome Measures
Name Time Method Secondary end point(s): Number of participants with change in disease status<br><br>;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)<br>