A Long-term Extension Study of PCI-32765 (Ibrutinib)
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
Study details:
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used.
Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol.
There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Participants must be currently participating in an ibrutinib clinical study considered complete 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 participants must have participated in an 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 participants with less than 6 months will be required to have more frequent initial safety assessments.
- Participants must be currently participating in study PCI-32765LYM1002.
- At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib.
- Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks.
- Agrees to protocol-defined use of effective contraception.
- Negative blood or urine pregnancy test at screening.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT01804686
Intervention or treatment
DRUG: Ibrutinib
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Waldenstrom Macroglobulinemia
- Chronic Graft Versus Host Disease
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal Adelaide Hospital
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, Australia
John Fawkner Cancer Trial Centre
Coburg, Australia
Concord Hospital
Concord, Australia
Austin Health
Heidelberg, Australia
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Who is running the clinical trial?
Janssen Research & Development, LLC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Ibrutinib
| Drug: Ibrutinib |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants affected by an adverse event | Not Specified | Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with change in disease status | Not Specified | Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier |
References
Clinical Trials Gov: A Long-term Extension Study of PCI-32765 (Ibrutinib)Other trials to consider
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