A Phase II Study Of Yttrium-ibritumomab (Zevalin) For the Treatment Of Patients With Relapsed And 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Followed for 4 years or until disease progression
Anas Younes, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|