Clinical trial NCT02556892: A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphocytic Leukemia
Keywords: Lymphocytic Leukemia
Ibrutinib
PCI-32765
JNJ-54179060
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensity of Adverse Events (AEs)
timeFrame: Screening up to follow-up phase (maximum of 24 months)
measure: Incidence of Adverse Events
timeFrame: 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
timeFrame: Pre-dose and 1, 2, and 4 hours post-dose on Day 1 of Cycle 1 and Cycle 2
measure: Overall Response Rate (Complete Response [CR] and Partial Response [PR])
timeFrame: 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
measure: Time to Response
timeFrame: 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
Other outcomes:
Locations:
city: Fukuoka-city
country: Japan
city: Hiroshima
country: Japan
city: Isehara
country: Japan
city: Kobe-city,
country: Japan
city: Koto-ku
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Tachikawa
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: