A Phase 2 interventional study of Yttrium-ibritumomab (Zevalin) and Rituximab in Lymphoma, Mantle-Cell, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-02.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Study of Yttrium-ibritumomab (Zevalin) For the treatment of Patients with Relapsed \& Refractory Mantle Cell Lymphoma
Mantle cell lymphoma cell express a protein called CD20. Ibritumomab tiuxetan is an antibody targeted against CD20, which carries a radioactive material called 90-Yttrium. The radioactivity will be delivered to the cancer cells by the antibody will help killing the mantle cell lymphoma cells. Before treatment starts, patients will have a physical exam, including blood and urine test. Patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken with a large needle. A cardiogram (EKG) will be performed before therapy and after 1 and 3 months of therapy.
Patients in this study will receive one dose of rituximab in the vein over 6 to 8 hours on the first day of treatment. This will be followed by an infusion of antibody labeled with radioactive indium, which will allow imaging of the tumor sites and normal tissue site that will bind the antibody.
Imaging will be performed twice in the nuclear medicine department of Day 1, and once on either Day 2 or 3. On day 8 (7 days after the first dose of rituximab), patients will receive a second dose of rituximab. This will immediately be followed by a dose of Ibritumomab tiuxetan given by vein over ten minutes. Patients will receive diphenhydramine (Benadryl) by vein and mouth and acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to prevent fever and chills. All treatments will be given in an outpatient setting.
Blood test will be taken weekly during the first 3 months, the every 3 months for 1 year, and then every 6 months for 3 years. CT scans, x-rays, and bone marrow biopsies will be repeated if needed after 3 months of therapy and every 3 months for 1 years, then every 6 months for 3 years. If tumors do not shrink after 3 months of therapy or increase in size, patients will be offered a different treatment.
This is an investigational study. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
After Rituximab infusion (250 mg/m\^2 intravenous) on Day 1, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Drug: Yttrium-ibritumomab (Zevalin) · Drug: Rituximab
After Rituximab infusion, 111\^In Zevalin on Day 1 followed by two whole body imaging performed on Day 1 then Day 2.
Also known as: 90-Yttrium-ibritumomab, Zevalin, IDEC-Y2B8, Ibritumomab, Ibritumomab tiuxetan
250 mg/m\^2 in the vein over 6 to 8 hours on Day 1.
Also known as: Rituxan
Number of Participants with Objective tumor response
Objective tumor response is defined as CR + CCR + PR, where CR = Complete Response, CCR = Clinical Complete Response and PR = partial response. All patients who receive any dose of Zevalin will be included in the calculation of response rate.
Time frame: Followed for 4 years or until disease progression
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center