Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
NCT ID: NCT00131313
Last Updated: 2005-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2003-01-31
2009-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Nipent, Cytoxan, Rituxan
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
* Known HIV or AIDS illness
* Thyroid disease requiring medication
* History of any malignancy that could affect the diagnosis or assessment of the study treatment
* Pregnancy or breast feeding
* Evidence of Hepatitis B or C infection
* Inability to comply with the requirements of the study
18 Years
ALL
No
Sponsors
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Mena, Raul, M.D.
INDIV
Pharmatech Oncology
INDUSTRY
Astex Pharmaceuticals, Inc.
INDUSTRY
East Valley Hematology and Oncology Medical Group
OTHER
Principal Investigators
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Raul Mena, MD
Role: PRINCIPAL_INVESTIGATOR
East Valley Hematology and Oncology Group
Locations
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Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States
East Valley Hematology and Oncology Medical Group
Burbank, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Lalita Pandit, MD, Inc.
Fountain Valley, California, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States
Robert A. Moss, M.D. FACP, Inc.
Fountain Valley, California, United States
Metropolitan Hematology Oncology Medical Group
Los Angeles, California, United States
North County Oncology
Oceanside, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Cancer and Blood Institute Medical Group
Rancho Mirage, California, United States
St. Teresa Comprehensive Cancer Center
Stockton, California, United States
Medical Group of North County
Vista, California, United States
The Oncology Clinic, PC
Colorado Springs, Colorado, United States
Mile High Oncology
Denver, Colorado, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Osceola Cancer Center
Kissimmee, Florida, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States
Augusta Oncology Associates, PC
Augusta, Georgia, United States
Spalding Oncology Services
Griffin, Georgia, United States
St Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Oncology Hematology Assoc. of Northern Illinois
Gurnee, Illinois, United States
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States
Arnett Cancer Care
Lafayette, Indiana, United States
Cancer Care Center
New Albany, Indiana, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, United States
Auerbach Hematology Oncology Associates, Inc.
Baltimore, Maryland, United States
Genesee Cancer & Blood Disease Treatment Center, PC
Flint, Michigan, United States
West Michigan Regional Cancer & Blood Center
Free Soil, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Branson Oncology Clinic
Branson, Missouri, United States
St. Louis Hematology Oncology Specialists, Inc.
St Louis, Missouri, United States
Sierra Nevada Oncology Care
Carson City, Nevada, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
Ellioth Fishkin, MD
Elizabeth, New Jersey, United States
Westchester Hematology Oncology Associates
Mount Kisco, New York, United States
Mid Dakota Clinic/Odyssey Research
Bismarck, North Dakota, United States
Summa Health System Hospitals
Akron, Ohio, United States
Nashat Y. Gabrail, MD, Inc.
Canton, Ohio, United States
Sambandam and Joseph Associates, Inc
Cranston, Rhode Island, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
The Family Cancer Center
Collierville, Tennessee, United States
C. Michael Jones, MD, PC
Germantown, Tennessee, United States
JPS Center for Cancer Care
Fort Worth, Texas, United States
Cache Valley Cancer Treatment & Research Clinic, Inc.
Logan, Utah, United States
Cancer Outreach Associates, PC
Abingdon, Virginia, United States
Virginia Oncology Care, PC
Richlands, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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James Daugherty, MD
Role: primary
Raul R Mena, MD
Role: primary
Robert L Robles, MD
Role: primary
Lalita Pandit, MD
Role: primary
Glen R Justice, MD
Role: primary
Robert A Moss, MD, FACP
Role: primary
Peter S Kennedy, MD
Role: primary
Warren S Paroly, MD
Role: primary
Rosemary E McIntyre, MD,PharmD
Role: primary
Robert H Lemon, MD
Role: primary
Neelesh S Bangalore, MD, PhD
Role: primary
Alberto Bessudo, MD
Role: primary
David Headley, DO
Role: primary
David Schrier, MD, DO
Role: primary
Eyal Meiri, MD
Role: primary
Medhi M Moezi, MD
Role: primary
Jorge G Otoya, MD
Role: primary
K.S. Kumar, MD
Role: primary
Roberto Arevalo-Araujo, MD,PharmD,PA
Role: primary
Mark R Keaton, MD
Role: primary
Rao Moravineni, MD
Role: primary
Theodore Walters, MD
Role: primary
Nilesh D Mehta, MD, FACP
Role: primary
Maureen Cooper, MD
Role: primary
Thomas I Jones, MD
Role: primary
Naveed Chowhan, MD
Role: primary
Hassan Ghazal, MD
Role: primary
Madhu Chaudhry, MD, MBBS
Role: primary
Yudhishtra Markan, MD
Role: primary
Michael Auerbach, MD, PharmD,FACP
Role: primary
Rizwan Danish, MD, FACP
Role: primary
Ahmed S Behairy, MD
Role: primary
Timothy O'Rourke, MD
Role: primary
Pairote Jaroonwanichkul, MD
Role: primary
Alvin Schergen, MD, PharmD,FACP
Role: primary
Jorge Perez-Cardona, MD
Role: primary
M. Nafees Nagy, MD
Role: primary
Stephen Zrada, MD
Role: primary
Ellioth Fishkin, MD
Role: primary
Gino Bottino, MD
Role: primary
Bipinkumar R Amin, MD
Role: primary
R. Douglas Trochelman, MD
Role: primary
Nashat Y Gabrail, MD
Role: primary
Plakyil J Joseph, MD
Role: primary
George F Geils, Jr., MD
Role: primary
Neal P Christiansen, MD
Role: primary
David Gravenor, MD
Role: primary
C. Michael Jones, MD, PC
Role: primary
Debra M Prow, MD
Role: primary
Ali Ben-Jacob, MD
Role: primary
Forrest Swan, MD
Role: primary
Madhaven V Pillai, MD, PharmD,FACP
Role: primary
Related Links
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Pharmatech - The Research Link website
Other Identifiers
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NIP-02-005
Identifier Type: -
Identifier Source: secondary_id
POI-02818
Identifier Type: -
Identifier Source: org_study_id