Study on Alemtuzumab and Ofatumumab for Untreated Symptomatic Chronic Lymphocytic Leukemia (CLL)
Sponsor: Northwestern University
ClinicalTrials ID:NCT01361711
This clinical trial is testing the combination of two drugs, alemtuzumab and ofatumumab, to see how well they work together in treating patients with chronic lymphocytic leukemia (CLL) who have not received any previous treatment. The study also aims to understand the side effects of this treatment.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the effectiveness and safety of combining two drugs, alemtuzumab and ofatumumab, in treating patients with chronic lymphocytic leukemia (CLL) who have not been treated before. These drugs are monoclonal antibodies that can help block cancer growth in different ways, such as stopping cancer from spreading or helping the immune system kill cancer cells. By using these drugs together, researchers hope to kill more cancer cells.
Description
In this study, patients will receive alemtuzumab under the skin three times a week for 18 weeks. They will also receive ofatumumab through an IV drip over 4-6 hours on specific days during weeks 3 to 17. After finishing the treatment, patients will be monitored for up to 5 years to check their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be in good general health with an ECOG performance status of 0 to 2.
- Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) with specific characteristics, such as a certain number of B lymphocytes in the blood and specific markers on the cancer cells.
- Must have symptoms that require treatment, such as significant weight loss, fatigue, fever, night sweats, worsening anemia, or enlarged spleen or lymph nodes.
- Must have adequate bone marrow function, with certain levels of neutrophils and platelets, unless low levels are due to CLL.
- Must have normal kidney and liver function as shown by specific blood tests.
- Must provide signed informed consent to participate in the study.
Exclusion Criteria
- Cannot have had previous cancer treatments, except for certain steroid treatments that were stopped at least a week before joining the study.
- Cannot have active autoimmune anemia or thrombocytopenia.
- Cannot have active liver or bile duct disease, except for certain conditions like Gilbert's syndrome.
- Cannot have active infections requiring antibiotics.
- Cannot have another active or recent cancer, except for certain skin cancers or pre-cancerous conditions.
- Cannot have HIV or certain hepatitis infections.
- Cannot have significant heart disease or recent stroke.
- Cannot have uncontrolled medical conditions that may pose a risk.
- Women of childbearing potential and sexually active men must use effective contraception during the study and for a year after the last treatment dose.
- Pregnant or breastfeeding women are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
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