Spots Global Cancer Trial Database for Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia
Official Title: Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT00003764
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously.
Detailed Description: OBJECTIVES: * Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia (CLL). * Compare the toxicities of these 2 regimens in this patient population. * Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells (i.e., p53; mdm2; GST; Bcl-2; Mcl-1; Bax; p27; and caspase-3) correlates with response to chemotherapy in these patients. * Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression. * Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (O-II vs III-IV). Patients are randomized to one of two treatment arms. * Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. * Arm II: Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months until disease progression. PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study over 2 to 2.5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Medical Center of Aurora - South Campus, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Presbyterian-St Luke's Medical Center, Denver, Colorado, United States
Rocky Mountain Cancer Centers - Rose, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, Thornton, Colorado, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Saint Anthony Medical Center, Rockford, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
Genesis Medical Center, Davenport, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Kansas Cancer Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Baptist Hospital East - Louisville, Louisville, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Tufts - New England Medical Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
Providence Cancer Institute at Providence Hospital, Southfield, Michigan, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
St. Louis University Hospital Cancer Center, Saint Louis, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon, New Hampshire, United States
Cooper University Hospital, Camden, New Jersey, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Clinical Cancer Center, Bronx, New York, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Elmhurst Hospital Center, Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
University Hospital at State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
NorthEast Oncology Associates, Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cape Fear Valley Health System, Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States
New Hanover Regional Medical Center, Wilmington, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Lifespan: The Miriam Hospital, Providence, Rhode Island, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Danville Radiation Therapy Center, Memphis, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Veterans Affairs Medical Center - Houston, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
Puget Sound Oncology Consortium, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
St. Mary's Medical Center, Huntington, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Ministry Medical Group - Northern Region, Rhinelander, Wisconsin, United States
McGill University, Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico
Pretoria Academic Hospital, Pretoria, , South Africa
Contact Details
Name: Ian W. Flinn, MD, PhD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
Name: Michael R. Grever, MD
Affiliation: Ohio State University Comprehensive Cancer Center
Role: STUDY_CHAIR
Name: Mohamad A. Hussein, MD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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