Multicenter Phase II Study for Zevalin® in Patients With Relapsed/Refractory Indolent Lymphomas: Extranodal Marginal Lymphoma of MALT Type, Nodal Marginal Zone B-Cell Lymphoma, and Splenic Marginal B-Cell Lymphoma
^90 Y Ibritumomab tiuxetan and rituximab are both designed to attach to lymphoma cells,
causing them to die.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. You will have a physical exam. Your blood (about 2 to 3 teaspoons) and urine will
be collected for routine tests. You will have a chest x-ray and computerized tomography
(CT) scans of the neck, chest, abdomen, and pelvis. You will have a bone marrow aspirate and
biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest
bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn
through a large needle. Women who are able to have children must have a negative blood
The study doctors will first make sure that your disease has not spread too much and is not
too severe to require immediate treatment with chemotherapy before you can begin treatment
on this study. If you are found to be eligible to take part in this study, you will be
given Benadryl (diphenhydramine) by vein, and you will be given Tylenol (acetaminophen) by
mouth before each dose of rituximab. This is done to help decrease the risk of developing
side effects of rituximab. You will then receive 1 dose of rituximab by vein over 6 to 8
hours on Day 1 of treatment. After treatment with rituximab, you will then be given a
radioactive antibody, ^111 In Ibritumomab tiuxetan (this is a radioactive agent that binds
to rituximab to help with imaging exams), by vein over about 10 minutes. This is so
researchers can use a special camera to see where the drug is in your body.
You will have imaging performed (with the special camera) on Day 1 and on either Day 2 or
Day 3. On Day 8, you will receive a second dose of rituximab. This will then be followed by
a dose ^90 Y Ibritumomab tiuxetan of given by vein over 10 minutes. This completes the
If you experience intolerable side effects while on this study, you may be removed from this
study. The study doctor will then offer other treatment options to you.
For your follow-up, you will have blood (about 2 tablespoons) drawn once a week for the
first 3 months, then every 3 months for 1 year, and then every 4 months for the second year.
At these visits, you may also have CT scans, x-rays, and bone marrow biopsies and aspirates
performed, if needed.
This is an investigational study. ^90 Y Ibritumomab tiuxetan and rituximab have been
approved by the FDA for the treatment of indolent B-cell lymphoma. Up to 35 patients will
take part in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.
Evaluation 4 weeks after administration of Zevalin up to 3 years
Felipe Samaniego, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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