NCT02556892

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

July 3, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

August 14, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

June 30, 2015

Last Update Submit

August 12, 2019

Conditions

Lymphocytic Leukemia

Keywords

Lymphocytic LeukemiaIbrutinibPCI-32765JNJ-54179060

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    Screening up to follow-up phase (maximum of 24 months)

Secondary Outcomes (3)

  • Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval

    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])

    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

    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

Study Arms (1)

Ibrutinib

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.

Drug: Ibrutinib

Interventions

IbrutinibDRUG

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
Ibrutinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kōtoku, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Tachikawa, Japan

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

September 22, 2015

Study Start

July 3, 2015

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

August 14, 2019

Record last verified: 2019-07

Locations

JP(8)