Description:
The purpose of this study is to collect long-term safety and efficacy data for participants
treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for
participants who are currently enrolled in PCI-32765 studies that have been completed
according to the parent protocol, are actively receiving treatment with PCI-32765, and who
continue to benefit from PCI-32765 treatment.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CR100955
- SECONDARY ID:
2012-004225-24
- SECONDARY ID:
PCI-32765CAN3001
- NCT ID:
NCT01804686
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Waldenstrom Macroglobulinemia
- Chronic Graft Versus Host Disease
Interventions
Drug | Synonyms | Arms |
---|
PCI-32765 (Ibrutinib) | | PCI-32765 (Ibrutinib) |
Purpose
The purpose of this study is to collect long-term safety and efficacy data for participants
treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for
participants who are currently enrolled in PCI-32765 studies that have been completed
according to the parent protocol, are actively receiving treatment with PCI-32765, and who
continue to benefit from PCI-32765 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 PCI-32765 (Ibrutinib) access to
participants in completed PCI-32765 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, "PCI-32765"will be
used. Participants will continue with the current PCI-32765 dosing regimen established in the
parent PCI-32765 study until the investigator determines that the participant is no longer
benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred),
the study is terminated by the sponsor, the participant withdraws consent, alternative access
to PCI-32765 is available and feasible, or for other reasons as defined in the protocol.
Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in
combination with the data collected in the parent protocol. Blood samples and a lymph node
biopsy sample for biomarker evaluations will be collected at the time of disease progression
or at the End of Treatment visit for participants who discontinue treatment without disease
progression (where local regulations and shipping logistics permit). There is no formal
hypothesis testing planned for this long-term extension study. Participants can receive
treatment with single-agent PCI-32765 and continue until end of study, which is defined as
the time of the last End-of-Treatment safety assessment for the last subject participating in
the study or 5 years after the last subject entered, or upon a decision by the sponsor to
terminate the study, whichever occurs earlier.
Trial Arms
Name | Type | Description | Interventions |
---|
PCI-32765 (Ibrutinib) | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Participants must be currently participating in a PCI-32765 clinical study considered
complete and have received at least 6 months of treatment with PCI-32765. At study
entry, participants must be actively receiving treatment with single-agent PCI-32765;
or participants must have participated in a PCI-32765 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 PCI-32765 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
- Investigator's assessment that the benefit of continued PCI-32765 therapy 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants affected by an adverse event |
Time Frame: | Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of participants with change in disease status |
Time Frame: | Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Enrolling by invitation |
Lead Sponsor: | Janssen Research & Development, LLC |
Trial Keywords
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
- Follicular lymphoma
- Diffuse large B-cell lymphoma
- PCI-32765
- Ibrutinib
- Bruton's tyrosine kinase inhibitor
- IMBRUVICA
- JNJ-54179060
Last Updated
August 20, 2021