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.
Title
- 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.
Clinical Trial IDs
- ORG STUDY ID:
PCYC-1145-LT
- NCT ID:
NCT03229200
Conditions
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Leukemia, B-cell
- Graft Vs Host Disease
- Solid Tumor
Interventions
| Drug | Synonyms | Arms |
|---|
| Ibrutinib | | Ibrutinib |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Ibrutinib | Experimental | Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity. | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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. |
| Safety Issue: | |
| Description: | Assessment of percentage of patients rolling over from each parent study. |
Secondary Outcome Measures
| Measure: | Characterize the drug safety profile by collecting long-term safety data for ibrutinib. |
| Time Frame: | Up to 3 years and will be re-evaluated. |
| Safety Issue: | |
| Description: | Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0. |
Details
| Phase: | Phase 4 |
| Primary Purpose: | Interventional |
| Overall Status: | Enrolling by invitation |
| Lead Sponsor: | Pharmacyclics Switzerland GmbH |
Last Updated
July 8, 2021
