Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ofatumumab by
vein every week for 4 weeks. After that, you will receive it every month. Each infusion
will last about 4 hours.
Before you receive ofatumumab, you will be given drugs to help reduce the risk of side
- You will take Tylenol (acetaminophen) by mouth.
- You will receive diphenhydramine by vein over about 5 minutes.
- You will receive a steroid by vein over about 5 minutes.
- You will take allopurinol by mouth during the first 14 days of treatment.
Every other week, blood (about 1 teaspoon) will be drawn for routine tests.
Every month, you will have a physical exam. If your doctor thinks it is needed, you will
also have a bone marrow biopsy to check the status of the disease.
After Month 6 and every 6 months after that, you will have a bone marrow biopsy and
aspiration to check the status of the disease.
Length of Treatment:
You may continue receive the study drug for up to 12 months. You will no longer be able to
take the study drug if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
This is an investigational study. Ofatumumab is FDA approved for the treatment of chronic
lymphocytic leukemia that has relapsed. Its use in this study for initial treatment of CLL
Up to 34 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Number of participants with Overall Response (OR) which equals Complete and Partial Responses (CR+PR) divided by total number of participants. Response assessed after month 3, month 6 and every 6 months thereafter using the 2008 National Cancer Institute (NCI) Working Group criteria for response.
Alessandra Ferrajoli, MD,BS
UT MD Anderson Cancer Center
United States: Institutional Review Board
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