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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01889069
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification system
* Currently being treated with rituximab intravenously (IV) in the Induction or Maintenance period, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square-meter (mg/m\^2) administered without interruption or early discontinuation (i.e. tolerability issues)
* Expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the Induction period or 6 additional cycles of treatment during the Maintenance period (participants with follicular NHL)
* An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion greater than or equal to (\>=) 7.5 centimeters (cm), or Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high risk) assessed before the first rituximab IV administration in Induction period
* At least one bi-dimensionally measurable lesion defined as \>=1.5 cm in its largest dimension on computed tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 3
Exclusion Criteria:
* Transformed lymphoma or FL IIIB
* Primary central nervous system lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, or primary cutaneous DLBCL
* History of other malignancy
* Ongoing corticosteroid use greater than (\>) 30 milligrams per day (mg/day) of prednisone or equivalent
* Inadequate renal, hematologic, or hepatic function
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindications to any of the individual components of standard chemotherapy
* Other serious underlying medical conditions, which, in the Investigator's judgement, could impair the ability of the participant to participate in the study
* Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)
* Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01889069
Study Brief:
Protocol Section:
NCT01889069