Last updated on August 2005

Efficacy and Safety of Nipent Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.


Brief description of study

This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.

Detailed Study Description

Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels. The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.

Clinical Study Identifier: NCT00131313

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Northwest Alabama Cancer Center, PC

Muscle Shoals, AL United States
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Lalita Pandit, MD, Inc.

Fountain Valley, CA United States
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Robert A. Moss, M.D. FACP, Inc.

Fountain Valley, CA United States
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Oceanside, CA United States
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Osceola Cancer Center

Kissimmee, FL United States
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New Port Richey, FL United States
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Pasco Pinellas Cancer Center

New Port Richey, FL United States
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Spalding Oncology Services

Griffin, GA United States
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Arnett Cancer Care

Lafayette, IN United States
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Cancer Care Center

New Albany, IN United States
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Kentucky Cancer Clinic

Hazard, KY United States
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Spectrum Health Hospitals

Grand Rapids, MI United States
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Branson Oncology Clinic

Branson, MO United States
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Sierra Nevada Oncology Care

Carson City, NV United States
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Nevada Cancer Center

Las Vegas, NV United States
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Ellioth Fishkin, MD

Elizabeth, NJ United States
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The Family Cancer Center

Collierville, TN United States
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C. Michael Jones, MD, PC

Germantown, TN United States
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JPS Center for Cancer Care

Fort Worth, TX United States
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Virginia Oncology Care, PC

Richlands, VA United States
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Recruitment Status: Open


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