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

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ClinicalTrials.gov Identifier: NCT01804686
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2013
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Waldenstrom Macroglobulinemia Chronic Graft Versus Host Disease Drug: PCI-32765 (Ibrutinib) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Actual Study Start Date : September 9, 2013
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: PCI-32765 (Ibrutinib) Drug: PCI-32765 (Ibrutinib)
PCI-32765 (Ibrutinib) will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent PCI-32765 clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804686


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Pharmacyclics LLC.
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01804686    
Other Study ID Numbers: CR100955
2012-004225-24 ( EudraCT Number )
PCI-32765CAN3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Waldenstrom Macroglobulinemia
Graft vs Host Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders