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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James Daugherty, MD

Northwest Alabama Cancer Center, PC
Muscle Shoals, AL United States
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Raul R Mena, MD

East Valley Hematology and Oncology Medical Group
Burbank, CA United States
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Robert L Robles, MD

Bay Area Cancer Research Group
Concord, CA United States
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Lalita Pandit, MD

Lalita Pandit, MD, Inc.
Fountain Valley, CA United States
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Glen R Justice, MD

Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, CA United States
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Robert A Moss, MD, FACP

Robert A. Moss, M.D. FACP, Inc.
Fountain Valley, CA United States
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Peter S Kennedy, MD

Metropolitan Hematology Oncology Medical Group
Los Angeles, CA United States
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Warren S Paroly, MD

North County Oncology
Oceanside, CA United States
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Rosemary E McIntyre, MD,PharmD

Ventura County Hematology Oncology Specialists
Oxnard, CA United States
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Robert H Lemon, MD

Cancer and Blood Institute Medical Group
Rancho Mirage, CA United States
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Neelesh S Bangalore, MD, PhD

St. Teresa Comprehensive Cancer Center
Stockton, CA United States
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Alberto Bessudo, MD

Medical Group of North County
Vista, CA United States
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David Headley, DO

The Oncology Clinic, PC
Colorado Springs, CO United States
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David Schrier, MD, DO

Mile High Oncology
Denver, CO United States
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Eyal Meiri, MD

Palm Beach Institute of Hematology and Oncology
Boynton Beach, FL United States
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Medhi M Moezi, MD

Integrated Community Oncology Network
Jacksonville, FL United States
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Jorge G Otoya, MD

Osceola Cancer Center
Kissimmee, FL United States
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K.S. Kumar, MD

Pasco Hernando Oncology Associates, PA
New Port Richey, FL United States
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Roberto Arevalo-Araujo, MD,PharmD,PA

Pasco Pinellas Cancer Center
New Port Richey, FL United States
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Mark R Keaton, MD

Augusta Oncology Associates, PC
Augusta, GA United States
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Rao Moravineni, MD

Spalding Oncology Services
Griffin, GA United States
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Theodore Walters, MD

St Luke's Mountain States Tumor Institute
Boise, ID United States
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Nilesh D Mehta, MD, FACP

Oncology Hematology Assoc. of Northern Illinois
Gurnee, IL United States
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Maureen Cooper, MD

Indiana Oncology Hematology Consultants
Indianapolis, IN United States
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Thomas I Jones, MD

Arnett Cancer Care
Lafayette, IN United States
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Naveed Chowhan, MD

Cancer Care Center
New Albany, IN United States
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Hassan Ghazal, MD

Kentucky Cancer Clinic
Hazard, KY United States
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Michael Auerbach, MD, PharmD,FACP

Auerbach Hematology Oncology Associates, Inc.
Baltimore, MD United States
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Yudhishtra Markan, MD

Chesapeake Oncology Hematology Associates
Baltimore, MD United States
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Madhu Chaudry, MD, MBBS

Greater Baltimore Medical Center
Baltimore, MD United States
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Rizwan Danish, MD, FACP

Genesee Cancer & Blood Disease Treatment Center, PC
Flint, MI United States
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Ahmed S Behairy, MD

West Michigan Regional Cancer & Blood Center
Freesoil, MI United States
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Timothy O'Rourke, MD

Spectrum Health Hospitals
Grand Rapids, MI United States
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Pairote Jaroonwanichkul, MD

Branson Oncology Clinic
Branson, MO United States
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Alvin Schergen, MD, PharmD,FACP

St. Louis Hematology Oncology Specialists, Inc.
St. Louis, MO United States
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Jorge Perez-Cardona, MD

Sierra Nevada Oncology Care
Carson City, NV United States
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M. Nafees Nagy, MD

Nevada Cancer Center
Las Vegas, NV United States
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Stephen Zrada, MD

The Center for Cancer and Hematologic Disease
Cherry Hill, NJ United States
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Ellioth Fishkin, MD

Ellioth Fishkin, MD
Elizabeth, NJ United States
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Gino Bottino, MD

Westchester Hematology Oncology Associates
Mount Kisco, NY United States
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Bipinkumar R Amin, MD

Mid Dakota Clinic/Odyssey Research
Bismarck, ND United States
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R. Douglas Trochelman, MD

Summa Health System Hospitals
Akron, OH United States
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Nashat Y Gabrail, MD

Nashat Y. Gabrail, MD, Inc.
Canton, OH United States
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Plakyil J Joseph, MD

Sambandam and Joseph Associates, Inc
Cranston, RI United States
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George F Geils, Jr., MD

Charleston Hematology Oncology, PA
Charleston, SC United States
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Neal P Christiansen, MD

South Carolina Oncology Associates
Columbia, SC United States
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David Gravenor, MD

The Family Cancer Center
Collierville, TN United States
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C. Michael Jones, MD, PC

C. Michael Jones, MD, PC
Germantown, TN United States
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Debra M Prow, MD

JPS Center for Cancer Care
Fort Worth, TX United States
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Ali Ben-Jacob, MD

Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan, UT United States
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Forest Swan, MD

Cancer Outreach Associates, PC
Abingdon, VA United States
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Madhaven V Pillai, MD, PharmD, ...

Virginia Oncology Care, PC
Richlands, VA United States
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