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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00933335
Eligibility Criteria:
Inclusion Criteria:
* Patients must be age 18 years or older.
* Patients must have a histologically-confirmed diagnosis of low-grade or follicular non-Hodgkin's B-cell lymphoma.
* Patients must have Ann Arbor stage III or IV extent of disease after completing staging.
* Patients must have bi-dimensionally measurable disease. At least one lesion must have both perpendicular diameters \> 2 cm.
* Patients must have evidence that their tumor expresses the CD20 antigen by immunohistochemistry or flow cytometry.
* Patients must have no previous treatment for NHL.
* Patients must have a Karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
* Patients must have absolute granulocyte count greater than or equal to 1500 cells/mm3 and a platelet count \> 100,000 cells/mm3 within 14 days of study entry and not require sustained support with hematopoietic cytokines or transfusion of blood products.
* Patients must have adequate renal and hepatic function.
* Patients must sign IRB approved informed consent form(s) prior to study entry.
Exclusion Criteria:
* Patients who received systemic steroids within 1 week of study entry, except patients on maintenance steroid therapy for a non-cancerous disease.
* Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry.
* Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
* Patients with known HIV Infection.
* Patients with known brain or leptomeningeal metastases.
* Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test at screening and on the day fludarabine treatment is started. Treatment is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the iodine I 131 tositumomab therapy.
* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
* Patients with hypersensitivity to fludarabine.
* Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
* Patients who are HAMA positive.
* Patients with previous allergic reaction to iodine. This does not include reacting to intravenous iodine containing contrast materials.
Inclusion Criteria for Iodine I 131 Tositumomab Therapy
* Patients who completed 3 cycles of fludarabine.
* Patients must have absolute granulocyte count ≥ to 1500/mm3, platelet count of ≥ 100,000/mm3 (≥ 150,000/mm3 if \> 25% bone marrow involvement at restaging), and not require sustained support with hematopoietic cytokines or transfusions with blood products.
* Patients must have adequate renal and hepatic function.
Exclusion criteria for Antibody Therapy
* Patients with active obstructive hydronephrosis.
* Patients with evidence of active infection requiring intravenous antibiotics.
* Patients who are pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00933335
Study Brief:
Protocol Section:
NCT00933335