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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00453102
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
* Measurable and evaluable disease
* All stages are eligible
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
* Willing and able to provide written informed consent
* Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
* Life expectancy of at least 6 months
Exclusion Criteria:
* Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
* ≥ 25% lymphoma bone marrow involvement
* Platelet count \< 100,000 cells/mm³
* Neutrophil count \< 1,500 cells/mm³
* Known history of HIV infection
* Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00453102
Study Brief:
Protocol Section:
NCT00453102