Lymphocytic Leukemia Clinical Trial
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
Verified date | July 2019 |
Source | Janssen Pharmaceutical K.K. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 8 |
Est. completion date | August 20, 2018 |
Est. primary completion date | August 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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 | ||
Secondary | 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. | 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 | |
Secondary | Time to Response | Time to response is defined as the time from the initial treatment until the first documented evidence of CR or 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00609869 -
Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab
|
Phase 2 | |
Active, not recruiting |
NCT05065866 -
Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy
|
Phase 1 | |
Completed |
NCT00013533 -
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies
|
Early Phase 1 | |
Completed |
NCT02481297 -
Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
|
Phase 2 | |
Withdrawn |
NCT00517218 -
This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)
|
Phase 3 | |
Completed |
NCT02434484 -
Symbenda Post-Marketing Surveillance (PMS)
|
||
Completed |
NCT00935792 -
Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT02885038 -
Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies
|
N/A | |
Completed |
NCT01499147 -
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
|
N/A | |
Recruiting |
NCT03219450 -
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
|
Phase 1 | |
Recruiting |
NCT05272813 -
A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
|
Phase 1/Phase 2 |