Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following: Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Phenotypically characterized as B-CLL Must have one of the following characteristics indicating need for chemotherapy: Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3) Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy At least 10% weight loss within 6 months of study Extreme fatigue Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection Night sweats without evidence of infection No autoimmune anemia or autoimmune thrombocytopenia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 mg/dL unless secondary to tumor Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL Other: No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix No active infection requiring oral or intravenous antibiotics Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: No prior steroid treatment for CLL Radiotherapy: Not specified Surgery: Not specified
Sites / Locations
- Northeast Alabama Regional Medical Center
- University of Alabama at Birmingham Comprehensive Cancer Center
- MBCCOP - Gulf Coast
- CCOP - Western Regional, Arizona
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of California Davis Cancer Center
- Veterans Affairs Medical Center - San Diego
- Veterans Affairs Medical Center - San Francisco
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Medical Center of Aurora - South Campus
- Boulder Community Hospital
- Penrose Cancer Center
- Porter Adventist Hospital
- St. Joseph Hospital
- Presbyterian-St Luke's Medical Center
- Rocky Mountain Cancer Centers - Rose
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- Rocky Mountain Cancer Centers
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- MBCCOP - Howard University Cancer Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Hospital Comprehensive Cancer Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- H. Lee Moffitt Cancer Center and Research Institute
- Palm Beach Cancer Institute
- Winship Cancer Institute of Emory University
- CCOP - Atlanta Regional
- Veterans Affairs Medical Center - Atlanta (Decatur)
- MBCCOP - Hawaii
- Veterans Affairs Medical Center - Lakeside Chicago
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Central Illinois
- CCOP - Evanston
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Saint Anthony Medical Center
- CCOP - Carle Cancer Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Hematology Oncology Associates of the Quad Cities
- CCOP - Cedar Rapids Oncology Project
- Genesis Medical Center
- CCOP - Iowa Oncology Research Association
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Cancer Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Baptist Hospital East - Louisville
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- CCOP - Ochsner
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Veterans Affairs Medical Center - Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tufts - New England Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Cancer Research Center at Boston Medical Center
- Beth Israel Deaconess Medical Center
- University of Massachusetts Memorial Medical Center - University Campus
- Veterans Affairs Medical Center - Ann Arbor
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Grand Rapids
- CCOP - Kalamazoo
- CCOP - Beaumont
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Providence Cancer Institute at Providence Hospital
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- Barnes-Jewish Hospital
- St. Louis University Hospital Cancer Center
- Missouri Baptist Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- Norris Cotton Cancer Center at Dartmouth Medical School
- Cooper University Hospital
- Veterans Affairs Medical Center - East Orange
- Cancer Institute of New Jersey
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Albany
- Albert Einstein Clinical Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center, NY
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- University Hospital at State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- New Hanover Regional Medical Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Veterans Affairs Medical Center - Fargo
- CCOP - Merit Care Hospital
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- MetroHealth Medical Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- Veterans Affairs Medical Center - Oklahoma City
- Cancer Institute at Oregon Health and Science University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Oncology Program
- CCOP - Geisinger Clinic and Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Western Pennsylvania Hospital
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- CCOP - MainLine Health
- Lifespan: The Miriam Hospital
- Veterans Affairs Medical Center - Charleston
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- CCOP - Sioux Community Cancer Consortium
- University of Tennessee Cancer Institute
- Danville Radiation Therapy Center
- Harrington Cancer Center
- Veterans Affairs Medical Center - Amarillo
- Veterans Affairs Medical Center - Dallas
- Medical City Dallas Hospital
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Veterans Affairs Medical Center - Houston
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- Green Mountain Oncology Group
- Vermont Cancer Center at University of Vermont
- Veterans Affairs Medical Center - White River Junction
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Inc.
- CCOP - Virginia Mason Research Center
- Veterans Affairs Medical Center - Seattle
- Puget Sound Oncology Consortium
- CCOP - Northwest
- Madigan Army Medical Center
- St. Mary's Medical Center
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
- Ministry Medical Group - Northern Region
- McGill University
- University of Puerto Rico School of Medicine Medical Sciences Campus
- Pretoria Academic Hospital