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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT01461928
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Cluster of Differentiation 20-positive (CD20+) follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to World Health Organization (WHO) classification system
* Participants must have received and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrollment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
Exclusion Criteria:
* Transformation to high-grade lymphoma
* Aggressive lymphoma (for example, mantle cell lymphoma \[MCL\])
* Presence or history of central nervous system (CNS) lymphomatous disease
* Other malignancy within 5 years prior to enrollment, except for curatively treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell skin cancer, or cervical carcinoma Stage 1B or less, breast cancer in situ or localized prostate cancer Stage T1c if treated with curative intent and relapse- and metastasis-free for at least 2 years prior to enrollment
* Inadequate hematological, hepatic or renal function
* Known human immunodeficiency virus (HIV) infection
* Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B or C)
* Pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01461928
Study Brief:
Protocol Section:
NCT01461928