A Phase II Study of R-FND, Followed by Zevalin Radioimmunotherapy, and Subsequent Maintenance Rituximab for Advanced Stage Follicular Lymphoma With High-Risk Features
The treatments used in this program include several standard chemotherapy agents
(fludarabine, mitoxantrone, and dexamethasone). Also, immune therapy agents will be given,
including rituximab (a monoclonal antibody that attacks B-cells, which is what this type of
lymphoma is made of), and Ibritumomab tiuxetan (another similar monoclonal antibody, which
delivers radiation to the lymphoma cells to strengthen the attack).
You will receive rituximab on Days 1 and 8 of the first cycle, and on Day 1 only of Cycles
2-4 of the monthly cycles of chemotherapy, called R-FND. R-FND includes rituximab and
fludarabine, mitoxantrone, and dexamethasone. Fludarabine will be given for 3 days,
mitoxantrone for 1 day, and dexamethasone for 5 days of each 28-day cycle (FND). After 4
cycles of R-FND, you will receive Ibritumomab tiuxetan. After the Ibritumomab tiuxetan, you
will receive rituximab every 2 months for 1 year. All are given by vein. Sometimes
dexamethasone can be given in pill form.
During the study, you will have blood tests (about 2 tablespoons), sometimes every week.
Every 2 cycles, you will have a chest x-ray and CT scans of the abdomen and pelvis. Bone
marrow samples will be taken. Heart function tests will be done as needed.
If you desire, it may be possible for you to receive some of your study treatment at home
(from your home doctor). Your study doctor will discuss this possibility with you. If this
is the case, your home doctor will receive a letter telling him about this study and asking
him if he wishes to participate in your treatments. He will be asked to provide the study
doctors at M. D. Anderson specific information about your treatments and any side effects
you may have. All communications between your home doctor and your study doctors will be
included as part of your M. D. Anderson medical record.
After the study ends, you will return for checkups every 3 months in the first year, every 4
months in Years 2 and 3, and every 6 months in Years 4 and 5. After that, checkups will be
needed once a year. Blood (about 2 tablespoons) and bone marrow samples will be taken at
This is an investigational study. Ibritumomab tiuxetan and rituximab are approved by the
FDA for commercial use. The other drugs used in the study are also approved for commercial
use by the FDA. About 50 patients will take part in the study. All will be enrolled at M.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Weekly blood tests and assessments every 2 cycles.
Nathan Fowler, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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