Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

• ClinicalTrials.gov Identifier: NCT03229200
• Recruitment Status: Enrolling by invitation
• First Posted: July 25, 2017
• Last Update Posted: December 9, 2019
• Sponsor: Pharmacyclics Switzerland GmbH
• Information provided by (Responsible Party): Pharmacyclics Switzerland GmbH

Tracking Information

• First Submitted Date: June 5, 2017
• First Posted Date: July 25, 2017
• Last Update Posted Date: December 9, 2019
• Actual Study Start Date: May 22, 2017
• Estimated Primary Completion Date: July 2, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2017)

The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. [ Time Frame: The duration will be 3 years and will be re-evaluated. ]

Assessment of percentage of patients rolling over from each parent study.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03229200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 24, 2017)

Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [ Time Frame: Up to 3 years and will be re-evaluated. ]

Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
• Official Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
• Brief Summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Detailed Description

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.

Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Leukemia, B-cell
• Graft Vs Host Disease
• Solid Tumor

Intervention

Drug: Ibrutinib

Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Study Arms

Experimental: Ibrutinib

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Intervention: Drug: Ibrutinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: July 24, 2017): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2, 2027
• Estimated Primary Completion Date: July 2, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
• Ongoing continuous treatment with ibrutinib.
• Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
• Subject has provided informed consent.
• 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 after the last dose of drug.

Exclusion Criteria:

• 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. Male subjects who plan to father a child while enrolled in this protocol.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, Czechia, France, Greece, Israel, Italy, New Zealand, Poland, Russian Federation, Spain, Sweden, Turkey, United States

Administrative Information

• NCT Number: NCT03229200
• Other Study ID Numbers: PCYC-1145-LT
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Pharmacyclics Switzerland GmbH
• Study Sponsor: Pharmacyclics Switzerland GmbH
• Collaborators: Not Provided

Investigators

• Study Director: Bernhard Hauns, MD; Pharmacyclics LLC.

• PRS Account: Pharmacyclics Switzerland GmbH
• Verification Date: December 2019