Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)
The goal of this clinical research study is to learn if ofatumumab can help to control Chronic Lymphocytic Leukemia (CLL). The safety of this drug will also be studied.
Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.
1. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with CLL.
- To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.
- To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.
- To determine the plasma levels of ofatumumab in elderly, unfit patients.
- To evaluate predictive capability of miRNAs detection in plasma samples
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)|
- Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Four weekly intravenous infusions at 300 mg during week 1, then 2,000 mg weeks 2, 3 and 4, then monthly during months 2-12.
Starting dose: 300 mg by vein during week 1, then 2000 mg in weeks 2, 3 and 4, then monthly during months 2-12.
Other Name: Arzerra
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 effects.
- 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 is investigational.
Up to 34 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
|Contact: Alessandra Ferrajoli, MD, BS||713-792-2063|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, MD,BS||UT MD Anderson Cancer Center|