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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT04745832
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
* Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
1. FL Gr 1, Gr 2, or Gr 3a
2. MZL (splenic, nodal, or extra-nodal)
* Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
* Subjects must have at least one bi-dimensionally measurable lesion \>1.5 cm
* Adequate hematologic parameters at screening unless abnormal values are due to disease
* Adequate renal and hepatic function
* Adequate cardiac function based on ECG and LVEF assessments
Exclusion Criteria:
* Histologically confirmed diagnosis of FL Gr 3b or transformed disease
* Prior therapy with PI3K inhibitors
* Ongoing or history of drug-induced pneumonitis
* Known lymphomatous involvement of the central nervous system
* Tested positive for or active viral infection with hepatitis B or C virus
* Tested positive or active infection with human immunodeficiency virus
* Tested positive, or active infection with human T-cell leukemia virus type 1
* Any uncontrolled clinically significant illness
* History of clinically significant cardiovascular abnormalities such as congestive heart failure
* History of clinically significant gastrointestinal (GI) conditions
* Females who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04745832
Study Brief:
Protocol Section:
NCT04745832