A Phase 1 interventional study of Ibrutinib in Lymphocytic Leukemia, sponsored by Janssen Pharmaceutical K.K.. Completed at 8 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Janssen Pharmaceutical K.K. · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).
This is a Phase 1, open-label and multicenter study. The study consists of a Screening Phase (28 days prior to the first administration of the study drug), Treatment Phase (time when the first dose of ibrutinib is administered until disease progression, the investigator no longer considers the treatment to be tolerable, or the participant meets any one of the discontinuation criteria) and Follow-up Phase (end of the last dose of study drug until 30 days after the last dose of study drug or the start of subsequent anti-CLL/SLL therapy, whichever comes first). Participants will be instructed to take 3 capsules of ibrutinib (at a dose of 420 mg) orally once daily starting at Cycle 1, Day 1. Participants' safety will be monitored throughout the study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 8 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
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Exclusion Criteria:
Participants will self-administer 420 milligram (mg) oral ibrutinib once daily continuously from Cycle 1 to Cycle 6 and thereafter every 28 days until treatment discontinuation.
Drug: Ibrutinib
Participants will self-administer 420 milligram (mg) oral ibrutinib once daily continuously from Cycle 1 to Cycle 6 and thereafter every 28 days until treatment discontinuation.
Also known as: PCI-32765, JNJ-54179060
Intensity of Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Intensity of Adverse Events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Time frame: Screening up to follow-up phase (maximum of 24 months)
Incidence of Adverse Events
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Time frame: Screening up to follow-up phase (maximum of 24 months)
Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval
Time frame: Pre-dose and 1, 2, and 4 hours post-dose on Day 1 of Cycle 1 and Cycle 2
Overall Response Rate (Complete Response [CR] and Partial Response [PR])
Tumor response will be evaluated according to the Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia (CLL) and the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, respectively.
Time frame: Days 1 of cycles 3,5,7 and every odd numbered cycle thereafter until disease progression, unacceptable toxicity or death whichever is first; expected average of 24 months
Time to Response
Time to response is defined as the time from the initial treatment until the first documented evidence of CR or PR.
Time frame: Days 1 of cycles 3,5,7 and every odd numbered cycle thereafter until disease progression, unacceptable toxicity or death whichever is first; expected average of 24 months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Janssen Pharmaceutical K.K.