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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib
EU CTIS ID: 2023-507329-40-00
What this study is testing
The primary objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib and to allow for continued treatment of drug combinations from the parent study for subjects who meet the selection criteria.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must have participated in an eligible ibrutinib clinical trial, may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician and does not have access to commercial ibrutinib within their region and/or the drug is not reasonably accessible to the patient within the respective region
- Ongoing continuous treatment with ibrutinib
- Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
- Subject or their legally authorized representative must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study
- Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days for females and males after the last dose of drug
- Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator discretion should be applied.
You likely can't join if
- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment
- Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol
- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment
- Unwilling or unable to participate in all required evaluations and procedures
- Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Ukraine
- Canada
- Turkey
- Russian Federation
- New Zealand
- United States
- Australia
- Taiwan
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Ukraine; Canada; Turkey; Russian Federation; New Zealand and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.