Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-08 @ 2:10 PM
Study NCT ID:
NCT01258933
Status:
TERMINATED
Last Update Posted:
2025-10-01
First Post:
2010-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be studied.
Detailed Description:
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.
Additional Information Depending on the results of your hepatitis tests performed at the screening visit, you may have additional hepatitis tests. The study staff will tell you if you will have these tests performed. If you do have the additional hepatitis tests, blood (about 2 teaspoons) will be drawn during Months 3-24. The blood will be drawn at the same time of the routine blood draws to prevent unnecessary needle sticks.
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.
Ofatumumab will be provided at no cost to you while you are on the study.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
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.
Additional Information Depending on the results of your hepatitis tests performed at the screening visit, you may have additional hepatitis tests. The study staff will tell you if you will have these tests performed. If you do have the additional hepatitis tests, blood (about 2 teaspoons) will be drawn during Months 3-24. The blood will be drawn at the same time of the routine blood draws to prevent unnecessary needle sticks.
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.
Ofatumumab will be provided at no cost to you while you are on the study.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-00274 | REGISTRY | NCI CTRP | View |