A Phase III Study of Interferon-Refractory Patients With BCR/ABL(+) Chronic Myelogenous Leukemia (CML) Treated With Homoharringtonine (NSC #141633) vs. Hydroxyurea
OBJECTIVES: I. Compare the overall survival of interferon alfa refractory chronic
myelogenous leukemia patients treated with homoharringtonine to those treated with
hydroxyurea. II. Compare the time to progression of these patients treated with these two
drugs. III. Estimate the complete and major cytogenetic response and describe the serial
cytogenetics of these patients treated with these two drugs.
OUTLINE: This is a randomized study. Patients are randomized to receive one of two
treatments. Arm I: Induction: Patients receive homoharringtonine IV continuously over 24
hours daily for 14 days. Induction continues every 28 days for a maximum of 6 courses or
until hematopoietic recovery. Maintenance: Patients receive homoharringtonine IV
continuously over 24 hours daily for 5 days. Treatment repeats every 28 days. Arm II:
Induction: Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts
are achieved. Maintenance: Patients receive oral hydroxyurea daily every 28 days to maintain
acceptable blood counts. Treatment in both arms continues for a minimum of 6 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 6
months for a maximum of 10 years.
PROJECTED ACCRUAL: A total of 480 patients (240 per arm) will be accrued for this study
within 4 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
4 years
No
Meir Wetzler, MD
Study Chair
Roswell Park Cancer Institute
United States: Food and Drug Administration
CDR0000067617
NCT00004933
January 2000
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of California Davis Medical Center | Sacramento, California 95817 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Loyola University Medical Center | Maywood, Illinois 60153 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Swedish Cancer Institute | Seattle, Washington 98104 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
North Shore University Hospital | Manhasset, New York 11030 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
Boston Medical Center | Boston, Massachusetts 02118 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Texas Tech University Health Science Center | Lubbock, Texas 79415 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |