Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
The Study Drug:
Ofatumumab is designed to bind to the surface of some white blood cells (B-cells) and to
kill these cells. It can destroy cancer cells that come from B-cells, and can be used to
treat cancers of B-cells such as B-CLL.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ofatumumab up
to 20 times during this study. You will receive 8 weekly infusions and then an infusion
every 2 months for 2 years or until the disease gets worse. You will receive ofatumumab by
vein over about 6 ½ hours the first time and over 4 hours for all the following infusions.
The first infusion will be the smallest dose. The second and later infusions will be 3 times
larger than the first.
Before you receive the study drug each time, you will receive Tylenol (acetaminophen) by
mouth to reduce the risk of fever. You will receive Benadryl (diphenhydramine) by mouth or
vein and prednisolone (a steroid) by vein over about 30 minutes to reduce the risk of an
allergic reaction or an infusion reaction.
During the infusions, you will be monitored closely. You will be expected to stay in clinic
for about 71/2 hours on the day of the first infusion and 5 hours for all other infusions.
You will be seen at MD Anderson for mandatory visits for enrollment, ofatumumab infusions,
for response assessment after 8 weekly ofatumumab doses (Month 3), during maintenance every
6 months and for follow-up at least once a year. Your local doctor may perform other visits
and laboratory studies.
If you decide to have your local doctor perform study visits and laboratory studies, a
letter will be sent to your doctor, describing your participation in this study and asking
for your doctor's agreement to help manage your care.
Study Visits:
The following tests and procedures will be performed every other week during Weeks 1- 8
(Weeks 1, 3, 5 and 7):
- You will have a complete physical exam including measurement of your vital signs.
- Your medical history will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will have the following tests and procedures every 2 Months:
- You will have a complete physical exam including measurement of your vital signs.
- Your medical history will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will also have the following tests and procedures every 6 months,
in addition to the ones performed every 2 months:
- Blood (about an additional 1 teaspoon) will be drawn for other routine tests.
- You may have CT scans to check the status of the disease, if your doctor thinks that
this test is needed (at Month 3 only).
- You will have a bone marrow aspirate/biopsy to check the status of the disease.
Length of Study:
You may continue taking the study drug for up to 20 doses (up to 24 months). You will no
longer be able to take the study drug if the disease gets worse or intolerable side effects
occur.
Your participation on the study will be over once you have completed the follow-up visits,
which will last until you begin receiving any other treatment.
Follow Up Visits:
Every 3 Months:
- You will have a complete physical exam including measurement of your vital signs.
- Your medical history will be recorded.
- Blood (about 2 teaspoons every 3 months, about 1 teaspoon every 6 months) will be drawn
for routine tests.
- If your doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for
hepatitis testing.
Every 6 Months, you will have a bone marrow aspirate/biopsy to check the status of the
disease.
This is an investigational study. Ofatumumab is FDA approved for CLL resistant to standard
chemotherapy. Ofatumumab's use in patients with residual CLL or SLL is investigational.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Objective Response
Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
Week 12
No
William G Wierda, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2010-0266
NCT01258933
July 2011
July 2015
Name | Location |
---|---|
U.T. M.D. Anderson Cancer Center | Houston, Texas 77030 |