Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02556892
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02556892
Study Brief:
Protocol Section:
NCT02556892