Overview

This trial is active, not recruiting.

Condition lymphocytic leukemia
Treatment ibrutinib
Phase phase 1
Target BTK
Sponsor Janssen Pharmaceutical K.K.
Start date July 2015
End date July 2018
Trial size 6 participants
Trial identifier NCT02556892, 54179060LEU1001, CR107620

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
ibrutinib PCI-32765
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.

Primary Outcomes

Measure
Intensity of Adverse Events (AEs)
time frame: Screening up to follow-up phase (maximum of 24 months)
Incidence of Adverse Events
time frame: Screening up to follow-up phase (maximum of 24 months)

Secondary Outcomes

Measure
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])
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 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

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Diagnosis of lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets published diagnostic criteria - For CLL participants: Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than (>) 1.5 centimeter (cm) at the longest diameter at a site that has not been previously irradiated. Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine; For SLL participants: At least 1 measurable site of disease according to the Revised Response Criteria for Malignant Lymphoma - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 × upper limit of normal (ULN), and total bilirubin less than or equal to (<=) 1.5 × ULN (unless due to Gilbert's syndrome) - A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening Exclusion Criteria: - Known involvement of the central nervous system by lymphoma or leukemia - History or current evidence of Richter's transformation or prolymphocytic leukemia - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura - Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL/SLL - Received any immunotherapy, live vaccine, or investigational drug within 4 weeks prior to the first dose of the study drug

Additional Information

Official title Phase 1 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Janssen Pharmaceutical K.K..