A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
Who is this study for? Patients with previously untreated or treated chronic lymphocytic leukemia
What treatments are being studied? Nipent+Cytoxan+Rituxan
Status: Unknown status
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• Stage II, III or IV Chronic Lymphocytic Leukemia
• Disease requires chemotherapeutic treatment
• CT or MRI scan confirming measurable tumor size
• Documentation of CD markers
• Up to one prior treatment regimen
• Expected survival greater than 6 months
• ECOG performance status of 0-2
• Adequate renal, bone marrow and liver functions
• Negative pregnancy test (females of childbearing potential)
• Must agree to use acceptable birth control, if fertile
• Must complete Informed Consent
• No heart disease and must have adequate cardiac function
• Must test negative for viral Hepatitis B and C
Locations
United States
Alabama
Northwest Alabama Cancer Center, PC
Recruiting
Muscle Shoals
California
East Valley Hematology and Oncology Medical Group
Recruiting
Burbank
Bay Area Cancer Research Group
Recruiting
Concord
Lalita Pandit, MD, Inc.
Recruiting
Fountain Valley
Pacific Coast Hematology/Oncology Medical Group, Inc.
Recruiting
Fountain Valley
Robert A. Moss, M.D. FACP, Inc.
Recruiting
Fountain Valley
Metropolitan Hematology Oncology Medical Group
Recruiting
Los Angeles
North County Oncology
Recruiting
Oceanside
Ventura County Hematology Oncology Specialists
Recruiting
Oxnard
Cancer and Blood Institute Medical Group
Recruiting
Rancho Mirage
St. Teresa Comprehensive Cancer Center
Recruiting
Stockton
Medical Group of North County
Recruiting
Vista
Colorado
The Oncology Clinic, PC
Recruiting
Colorado Springs
Mile High Oncology
Recruiting
Denver
Florida
Palm Beach Institute of Hematology and Oncology
Recruiting
Boynton Beach
Integrated Community Oncology Network
Recruiting
Jacksonville
Osceola Cancer Center
Recruiting
Kissimmee
Pasco Hernando Oncology Associates, PA
Recruiting
New Port Richey
Pasco Pinellas Cancer Center
Recruiting
New Port Richey
Georgia
Augusta Oncology Associates, PC
Recruiting
Augusta
Spalding Oncology Services
Recruiting
Griffin
Idaho
St Luke's Mountain States Tumor Institute
Recruiting
Boise
Illinois
Oncology Hematology Assoc. of Northern Illinois
Recruiting
Gurnee
Indiana
Indiana Oncology Hematology Consultants
Recruiting
Indianapolis
Arnett Cancer Care
Recruiting
Lafayette
Cancer Care Center
Recruiting
New Albany
Kentucky
Kentucky Cancer Clinic
Recruiting
Hazard
Maryland
Auerbach Hematology Oncology Associates, Inc.
Recruiting
Baltimore
Chesapeake Oncology Hematology Associates
Recruiting
Baltimore
Greater Baltimore Medical Center
Recruiting
Baltimore
Michigan
Genesee Cancer & Blood Disease Treatment Center, PC
Recruiting
Flint
West Michigan Regional Cancer & Blood Center
Recruiting
Freesoil
Spectrum Health Hospitals
Recruiting
Grand Rapids
Missouri
Branson Oncology Clinic
Recruiting
Branson
St. Louis Hematology Oncology Specialists, Inc.
Recruiting
St. Louis
North Dakota
Mid Dakota Clinic/Odyssey Research
Recruiting
Bismarck
New Jersey
The Center for Cancer and Hematologic Disease
Recruiting
Cherry Hill
Ellioth Fishkin, MD
Recruiting
Elizabeth
Nevada
Sierra Nevada Oncology Care
Recruiting
Carson City
Nevada Cancer Center
Recruiting
Las Vegas
New York
Westchester Hematology Oncology Associates
Recruiting
Mount Kisco
Ohio
Summa Health System Hospitals
Recruiting
Akron
Nashat Y. Gabrail, MD, Inc.
Recruiting
Canton
Rhode Island
Sambandam and Joseph Associates, Inc
Recruiting
Cranston
South Carolina
Charleston Hematology Oncology, PA
Recruiting
Charleston
South Carolina Oncology Associates
Recruiting
Columbia
Tennessee
The Family Cancer Center
Recruiting
Collierville
C. Michael Jones, MD, PC
Recruiting
Germantown
Texas
JPS Center for Cancer Care
Recruiting
Fort Worth
Utah
Cache Valley Cancer Treatment & Research Clinic, Inc.
Recruiting
Logan
Virginia
Cancer Outreach Associates, PC
Recruiting
Abingdon
Virginia Oncology Care, PC
Recruiting
Richlands
Contact Information
Primary
Tracy Latimer
tracyl@pharmatech.com
720-917-7478
Time Frame
Start Date: January 2003
Completion Date: April 2009
Participants
Target number of participants: 180
Authors
David Gravenor, K.S. Kumar, M. Nafees Nagy, Medhi M Moezi, Madhaven V Pillai, Forest Swan, Mark R Keaton, Madhu Chaudry, Lalita Pandit, Yudhishtra Markan, Michael Auerbach, Pairote Jaroonwanichkul, Peter S Kennedy, Rizwan Danish, Glen R Justice, Maureen Cooper, Bipinkumar R Amin, Nilesh D Mehta, Rao Moravineni, Hassan Ghazal, Neal P Christiansen, Robert H Lemon, Naveed Chowhan, Plakyil J Joseph, Neelesh S Bangalore, David Headley, Nashat Y Gabrail, Eyal Meiri, Rosemary E McIntyre, Ahmed S Behairy, Theodore Walters, Thomas I Jones, Alberto Bessudo, Stephen Zrada, Jorge G Otoya, C. Michael Jones, Robert A Moss, David Schrier, Debra M Prow, Raul R Mena, Alvin Schergen, James Daugherty, Gino Bottino, Warren S Paroly, Robert L Robles, Jorge Perez-Cardona, Timothy O'Rourke, Ali Ben-Jacob, Roberto Arevalo-Araujo, Ellioth Fishkin, R. Douglas Trochelman, George F Geils
Related Therapeutic Areas
Sponsors
Collaborators: Mena, Raul, M.D., Astex Pharmaceuticals, Inc., Pharmatech Oncology
Leads: East Valley Hematology and Oncology Medical Group