Overview

A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status:
Completed
Trial end date:
2018-08-20
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
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