Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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.
Patients with active obstructive hydronephrosis.
Patients with evidence of active infection requiring intravenous antibiotics.
Patients who are pregnant.
Clareo Health | Study of Safety and Efficacy of a Sequential Regimen Consisting of Three Cycles of Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab
