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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03768505
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme
1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
* Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
* Age ≥ 18
* At least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
* Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
* QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
* Left ventricular ejection fraction (LVEF) ≥ 45%
Exclusion Criteria:
* Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
* Known lymphomatous involvement of the central nervous system
* Uncontrolled clinically significant illness
* Ongoing or history of drug-induced pneumonitis
* History of clinically significant cardiovascular abnormalities
* History of clinically significant GI conditions
* Known history of, or active HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03768505
Study Brief:
Protocol Section:
NCT03768505