A Long-term Extension Study of PCI-32765 (Ibrutinib)

Brief Title

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Official Title

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of participants affected by an adverse event

Secondary Outcome

 Number of participants with change in disease status

Condition

Chronic Lymphocytic Leukemia

Intervention

Ibrutinib

Study Arms / Comparison Groups

 Ibrutinib

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

700

Start Date

September 9, 2013

Completion Date

January 29, 2027

Primary Completion Date

December 31, 2026

Eligibility Criteria

        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; or 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Janssen Research & Development, LLC Clinical Trial, , 

Location Countries

Argentina

Location Countries

Argentina

NCT ID

NCT01804686

Organization ID

CR100955

Secondary IDs

2012-004225-24

Responsible Party

Sponsor

Study Sponsor

Janssen Research & Development, LLC

Collaborators

 Pharmacyclics LLC.

Study Sponsor

Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC

Verification Date

March 2023