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

Primary Purpose

Lymphocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Ibrutinib

About this trial

This is an interventional treatment trial for Lymphocytic Leukemia focused on measuring Lymphocytic Leukemia, Ibrutinib, PCI-32765, JNJ-54179060

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibrutinib

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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

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 to Response

Time to response is defined as the time from the initial treatment until the first documented evidence of CR or PR.

Full Information

NCT ID

NCT02556892

First Posted

June 30, 2015

Last Updated

August 12, 2019

Sponsor

Janssen Pharmaceutical K.K.

1. Study Identification

Unique Protocol Identification Number

NCT02556892

Brief Title

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

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 3, 2015 (Actual)

Primary Completion Date

August 20, 2018 (Actual)

Study Completion Date

August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Pharmaceutical K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphocytic Leukemia

Keywords

Lymphocytic Leukemia, Ibrutinib, PCI-32765, JNJ-54179060

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibrutinib

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ibrutinib

Other Intervention Name(s)

PCI-32765, JNJ-54179060

Intervention Description

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 Outcome Measure Information:

Title

Intensity of Adverse Events (AEs)

Description

Time Frame

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

Title

Incidence of Adverse Events

Description

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)

Secondary Outcome Measure Information:

Title

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

Title

Overall Response Rate (Complete Response [CR] and Partial Response [PR])

Description

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

Title

Time to Response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Pharmaceutical K.K., Japan Clinical Trial

Organizational Affiliation

Janssen Pharmaceutical K.K.

Official's Role

Study Director

Facility Information:

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

12. IPD Sharing Statement

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR107620&attachmentIdentifier=2d0a9e6d-8e4a-4ec2-a334-bf738f197d66&fileName=CR107620_CSR_Synopsis.pdf&versionIdentifier=

Description

Phase 1 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Learn more about this trial

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

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