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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556892
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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).

Condition or disease Intervention/treatment Phase
Lymphocytic Leukemia Drug: Ibrutinib Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 3, 2015
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018


Arm Intervention/treatment
Experimental: Ibrutinib
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
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.
Other Names:
  • PCI-32765
  • JNJ-54179060




Primary Outcome Measures :
  1. Intensity of Adverse Events (AEs) [ Time Frame: Screening up to follow-up phase (maximum of 24 months) ]
    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).

  2. Incidence of Adverse Events [ Time Frame: Screening up to follow-up phase (maximum of 24 months) ]
    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 :
  1. 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 ]
  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 ]
    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.

  3. 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 ]
    Time to response is defined as the time from the initial treatment until the first documented evidence of CR or PR.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556892


Locations
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Japan
Fukuoka-city, Japan
Hiroshima, Japan
Isehara, Japan
Kobe-city,, Japan
Koto-ku, Japan
Osaka, Japan
Sapporo, Japan
Tachikawa, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02556892     History of Changes
Other Study ID Numbers: CR107620
54179060LEU1001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Janssen Pharmaceutical K.K.:
Lymphocytic Leukemia
Ibrutinib
PCI-32765
JNJ-54179060
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell