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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT00493467
Eligibility Criteria:
Inclusion Criteria:
1. New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
2. Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
3. Signed Informed Consent.
4. Age \>/= 18 years.
5. Pre-study Zubrod performance status of 0, 1, or 2.
6. Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC) \>/= 1, 500/mm\^3, total lymphocyte count \</= 5,000/mm\^3 and platelet counts \>/= 100,000/mm\^3.
7. Female patients who are not pregnant or lactating.
8. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
9. Patients determined to have \< 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).
10. Patient should have at least one lesion measuring \>/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.
Exclusion Criteria:
1. Presence of central nervous system (CNS) lymphoma.
2. Patients with HIV or AIDS-related lymphoma.
3. Patients with pleural effusion.
4. Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL.
5. Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL.
6. Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional).
7. Impaired bone marrow reserve as indicated by \< 15% bone marrow cellularity
8. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
9. Major surgery, other than diagnostic surgery, within four weeks.
10. Evidence of transformation in the latest biopsy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00493467
Study Brief:
Protocol Section:
NCT00493467