ong-term safety of Ibrutinib

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Subject must currently be participating 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 thave access to commercial ibrutinib within their region (eg, no regulatory approval ,insufficient reimbursement, and/or insufficient insurer coverage for the indication).
2. Ongoing continuous treatment with ibrutinib: ibrutinib treatment may be on temporary hold at the time of enrollment with less than 28 continuous doses missed, however, the decision cannot have been made to permanently discontinue ibrutinib treatment. The sponsor reserves the right to not roll-over patients that have been on drug hold for an extended time period.
3. Subject must have completed all assessments in their parent protocol (eg, End-of-Treatment Visit is completed) and want to continue treatment with ibrutinib.
4.Subject has provided informed consent to the long-term treatment extension protocol and not withdrawn consent from the parent study.
5.Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (as desribed in the protocol) during the period of therapy and for 90 days for females and males after the last dose of drug.
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
2. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol.
3. 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.
4. Unwilling or unable to participate in all required evaluations and procedures.
5. 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(in accordance with national and local subject privacy regulations).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 9/2/2024

ong-term safety of Ibrutinib

Recruitment & Eligibility

Study & Design

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