RATIONALE: Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia. PURPOSE: This randomized...
Date First Received: November 1, 1999
Last Updated: July 19, 2008
Verified by: National Cancer Institute (NCI), November 2004
Clinical Trial Phase: Phase 3 | Start Date: June 1999
Overall Status: Active, not recruiting
Estimated Enrollment: 522
Brief Summary
Official Title: “Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (As2O3) (NSC# 706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients With Untreated Acute Promyelocytic Leukemia”
Condition Keyword(s):
RATIONALE: Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia.
PURPOSE: This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously.
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Detailed Clinical Trial Description
OBJECTIVES: - Compare the efficacy (event-free survival) and toxicity of tretinoin, cytarabine, and daunorubicin with or without arsenic trioxide as induction/consolidation therapy in patients with previously untreated acute promyelocytic leukemia. - Evaluate the efficacy (disease-free survival) and toxicity of intermittent tretinoin with or without mercaptopurine and methotrexate as maintenance therapy in these patients who achieve a complete response after induction/consolidation therapy. - Determine the relationship between CD56 expression at diagnosis and clinical outcomes in these patients treated with this regimen. - Evaluate the cardiac toxicity of intensive daunorubicin therapy in pediatric patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 15 vs 15 to 60 vs over 60) for the induction phase. Patients are stratified according to age, as in the induction phase, and the consolidation arm (with vs without arsenic trioxide) for the consolidation phase. Patients under age 5 do not receive arsenic trioxide. - Induction: All patients receive oral tretinoin every 12 hours beginning on day 1 until complete response or for a maximum of 90 days. Patients also receive daunorubicin IV on days 3-6 and cytarabine IV continuously on days 3-9. - Consolidation: All patients achieving complete response (CR), or partial response (PR) after completion of tretinoin, proceed to consolidation within 2 weeks of achieving CR or PR, but not prior to 30 days from the start of induction. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral tretinoin every 12 hours on days 1-7 and daunorubicin IV on days 1-2 or days 1-3, depending on age. Patients may receive an additional course. Treatment begins no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery. - Arm II: Patients receive arsenic trioxide IV over 2 hours daily 5 days a week for 5 weeks. After a 2-week rest, patients receive a second course of arsenic trioxide.
Patients then receive tretinoin and daunorubicin as in arm I. - Maintenance: Patients maintaining CR or PR after consolidation therapy proceed to maintenance therapy, beginning no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral tretinoin every 12 hours for 7 days every other week for 1 year. - Arm II: Patients receive oral tretinoin as in arm I above. Patients also receive oral mercaptopurine once a day and oral methotrexate once weekly for up to 1 year.
Maintenance therapy continues for up to 1 year in the absence of unacceptable toxicity.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 522 patients (456 adults and 66 pediatric) will be accrued for this study within 4.75 years.
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Clinically diagnosed, previously untreated acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by reverse transcriptase polymerase chain reaction
- M3 characteristics by aspirate smear
- At least 30% of cells must be abnormal promyelocytes with heavy granulation
- Overall marrow cellularity must be normocellular or hypercellular
- Microgranular variant (M3V) eligible
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent growth factors, except filgrastim (G-CSF) or sargramostim (GM-CSF) for life-threatening clinical deterioration (e.g., severe pneumonia, hypotension, multiorgan dysfunction, or fungal infection)
Chemotherapy:
- No prior cytotoxic chemotherapy for APL
- Prior hydroxyurea allowed
Endocrine therapy:
- Prior corticosteroids allowed
Radiotherapy:
- No concurrent palliative radiotherapy
Surgery:
- Not specified
Other:
- Prior leukapheresis allowed
- No prior retinoids for APL
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Cancer and Leukemia Group B
MBCCOP - Gulf Coast
Mobile Alabama 36607 United States
Northeast Alabama Regional Medical Center
Anniston Alabama 36207 United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama 35233 United States
University of South Alabama Cancer Research Institute
Mobile Alabama 36604 United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson Arizona 85724 United States
CCOP - Western Regional, Arizona
Phoenix Arizona 85006-2726 United States
Phoenix Children's Hospital
Phoenix Arizona 85016 United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona 85012 United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona 85723 United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas 72205 United States
Veterans Affairs Medical Center - Little Rock
Little Rock Arkansas 72205 United States
CCOP - Bay Area Tumor Institute
Oakland California 94609-3305 United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California 95403 United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange California 92868 United States
Children's Hospital and Health Center, San Diego
San Diego California 92123-4282 United States
Children's Hospital and Research Center at Oakland
Oakland California 94609-1809 United States
Children's Hospital Central California
Madera California 93638-8762 United States
Children's Hospital Los Angeles
Los Angeles California 90027-0700 United States
Children's Hospital of Orange County
Orange California 92868 United States
City of Hope Comprehensive Cancer Center
Duarte California 91010-3000 United States
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base California 94535 United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach California 90801-1428 United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California 90095-1781 United States
Kaiser Permanente Medical Center - Sacramento
Sacramento California 95825 United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara California 95051-5386 United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego California 92120 United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda California 92354 United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto California 94304 United States
Naval Medical Center - San Diego
San Diego California 92134-3202 United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California 92093-0658 United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles California 90048 United States
Santa Barbara Cottage Hospital
Santa Barbara California 93102 United States
Southern California Permanente Medical Group
Downey California 90242 United States
Sutter Cancer Center
Sacramento California 95816 United States
UCSF Comprehensive Cancer Center
San Francisco California 94115 United States
University of California Davis Cancer Center
Sacramento California 95817 United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California 90033 United States
Veterans Affairs Medical Center - San Diego
San Diego California 92161 United States
Veterans Affairs Medical Center - San Francisco
San Francisco California 94121 United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California 94553 United States
Boulder Community Hospital
Boulder Colorado 80301-9019 United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado 80224 United States
Children's Hospital Cancer Center
Denver Colorado 80218 United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado 80501 United States
Medical Center of Aurora - South Campus
Aurora Colorado 80012-0000 United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado 80933 United States
Porter Adventist Hospital
Denver Colorado 80210 United States
Presbyterian - St. Luke's Medical Center
Denver Colorado 80218 United States
Rocky Mountain Cancer Centers - Denver Rose
Denver Colorado 80220 United States
Rocky Mountain Cancer Centers - Thornton
Thornton Colorado 80229 United States
Sky Ridge Medical Center
Lone Tree Colorado 80124 United States
St. Joseph Hospital
Denver Colorado 80218-1191 United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado 81004 United States
Swedish Medical Center
Englewood Colorado 80112 United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado 80010 United States
Veterans Affairs Medical Center - Denver
Denver Colorado 80220 United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington Connecticut 06360-7106 United States
Yale Comprehensive Cancer Center
New Haven Connecticut 06520-8064 United States
Alfred I. duPont Hospital for Children
Wilmington Delaware 19899 United States
CCOP - Christiana Care Health Services
Newark Delaware 19713 United States
Children's National Medical Center
Washington District of Columbia 20010-2970 United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington District of Columbia 20007 United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia 20060 United States
Veterans Affairs Medical Center - Washington, DC
Washington District of Columbia 20422 United States
All Children's Hospital
St. Petersburg Florida 33701 United States
Baptist-South Miami Regional Cancer Program
Miami Florida 33176-2197 United States
Broward General Medical Center
Fort Lauderdale Florida 33316 United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida 33140 United States
Children's Hospital of Southwest Florida
Fort Myers Florida 33908 United States
Florida Hospital Cancer Institute
Orlando Florida 32804 United States
Jackson Memorial Hospital
Miami Florida 33136 United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood Florida 33021 United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood Florida 33021 United States
Miami Children's Hospital
Miami Florida 33155 United States
Nemours Children's Clinic
Jacksonville Florida 32207 United States
Nemours Children's Clinic-Orlando
Orlando Florida 32806 United States
Palm Beach Cancer Institute - West Palm Beach
West Palm Beach Florida 33401 United States
Sacred Heart Children's Hospital
Pensacola Florida 32504 United States
St. Joseph's Children's Hospital
Tampa Florida 33677-4227 United States
St. Mary's Hospital
West Palm Beach Florida 33407 United States
University of Florida Shands Cancer Center
Gainesville Florida 32610-0296 United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida 33612 United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta Georgia 30342 United States
CCOP - Atlanta Regional
Atlanta Georgia 30342-1701 United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia 31405 United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta Georgia 30912-4000 United States
Medical Center of Central Georgia
Macon Georgia 31201 United States
Cancer Research Center of Hawaii
Honolulu Hawaii 96813 United States
MBCCOP - Hawaii
Honolulu Hawaii 96813 United States
Tripler Army Medical Center
Honolulu Hawaii 96859-5000 United States
Mountain States Tumor Institute - Boise
Boise Idaho 83712 United States
Advocate Hope Children's Hospital
Oak Lawn Illinois 60453 United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois 60153-5500 United States
CCOP - Carle Cancer Center
Urbana Illinois 61801 United States
CCOP - Central Illinois
Decatur Illinois 62526 United States
CCOP - Evanston
Evanston Illinois 60201 United States
CCOP - Illinois Oncology Research Association
Peoria Illinois 61615-7828 United States
Children's Memorial Hospital - Chicago
Chicago Illinois 60614 United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois 60521 United States
Louis A. Weiss Memorial Hospital
Chicago Illinois 60640 United States
Lutheran General Cancer Care Center
Park Ridge Illinois 60068-1174 United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois 60612 United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois 60611 United States
Rush University Medical Center
Chicago Illinois 60612 United States
Saint Jude Midwest Affiliate
Peoria Illinois 61637 United States
Southern Illinois University School of Medicine
Springfield Illinois 62794-9658 United States
University of Chicago Cancer Research Center
Chicago Illinois 60601 United States
University of Illinois Medical Center
Chicago Illinois 60612 United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois 60612 United States
Veterans Affairs Medical Center - Hines
Hines Illinois 60141 United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois 60611-4494 United States
West Suburban Center for Cancer Care
River Forest Illinois 60305 United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne Indiana 46885-5099 United States
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis Indiana 46202-5225 United States
St. Vincent Hospitals and Health Care Centers
Indianapolis Indiana 46260 United States
Blank Children's Hospital
Des Moines Iowa 50309 United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa 52242-1009 United States
CCOP - Wichita
Wichita Kansas 67214-3882 United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas 66160-7353 United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas 67218 United States
Wesley Medical Center
Wichita Kansas 67214 United States
Baptist Hospital East - Louisville
Louisville Kentucky 40207 United States
Kosair Children's Hospital
Louisville Kentucky 40202-3830 United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky 40536-0284 United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky 40502-2236 United States
CCOP - Ochsner
New Orleans Louisiana 70121 United States
Children's Hospital of New Orleans
New Orleans Louisiana 70118 United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana 71130-3932 United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana 70112 United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans Louisiana 70121 United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans Louisiana 70112 United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana 71101-4295 United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor Maine 04401 United States
Maine Children's Cancer Program
Scarborough Maine 04074-9308 United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore Maryland 21215 United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland 21201 United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland 21231-2410 United States
Walter Reed Army Medical Center
Silver Spring Maryland 20910 United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield Massachusetts 01107 United States
Cancer Center at Tufts - New England Medical Center
Boston Massachusetts 02111 United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts 02118 United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts 02115 United States
Floating Hospital for Children
Boston Massachusetts 02111 United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts 01655 United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan 48201-1379 United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing Michigan 48910 United States
Bronson Methodist Hospital
Kalamazoo Michigan 49007-5364 United States
CCOP - Grand Rapids
Grand Rapids Michigan 49503 United States
CCOP - Kalamazoo
Kalamazoo Michigan 49007-3731 United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan 48106 United States
Children's Hospital of Michigan
Detroit Michigan 48201 United States
DeVos Children's Hospital
Grand Rapids Michigan 49503 United States
Hurley Medical Center
Flint Michigan 48503 United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit Michigan 48202 United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan 49085 United States
Providence Cancer Institute at Providence Hospital - Southfield
Southfield Michigan 48075 United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan 48109-0948 United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit Michigan 48236 United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan 48201-1932 United States
William Beaumont Hospital - Royal Oak
Royal Oak Michigan 48073-6769 United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota 55416 United States
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis Minnesota 55404 United States
Mayo Clinic Cancer Center
Rochester Minnesota 55905 United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota 55805 United States
University of Minnesota Cancer Center
Minneapolis Minnesota 55455 United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota 55417-2399 United States
University of Mississippi Medical Center
Jackson Mississippi 39216-4505 United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi 39216 United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri 63104 United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri 65807 United States
CCOP - Kansas City
Kansas City Missouri 64131 United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri 63141 United States
Children's Mercy Hospital
Kansas City Missouri 64108 United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri 65203 United States
Saint Louis University Cancer Center
Saint Louis Missouri 63110 United States
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis Missouri 63110 United States
St. Louis Children's Hospital
Saint Louis Missouri 63110 United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri 65201 United States
CCOP - Montana Cancer Consortium
Billings Montana 59101 United States
Children's Hospital of Omaha
Omaha Nebraska 68114 United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska 68198-7680 United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada 89106 United States
Sunrise Hospital and Medical Center
Las Vegas Nevada 89109 United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas Nevada 89106 United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett New Hampshire 03106 United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire 03756 United States
Cancer Center at Hackensack University Medical Center
Hackensack New Jersey 07601 United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden New Jersey 08103 United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey 08903 United States
Cooper Cancer Institute
Voorhees New Jersey 08043 United States
Newark Beth Israel Medical Center
Newark New Jersey 07112-2094 United States
St. Joseph's Hospital and Medical Center
Paterson New Jersey 07503 United States
Tomorrows Children's Institute
Hackensack New Jersey 07601 United States
Valerie Fund Children's Center at Atlantic Health
Summit New Jersey 07901 United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico 87131 United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque New Mexico 87131 United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico 87108-5138 United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York 10461 United States
Brookdale University Hospital and Medical Center
Brooklyn New York 11212 United States
Brooklyn Hospital Center
Brooklyn New York 11201-5493 United States
Cancer Center of Albany Medical Center
Albany New York 12208 United States
CCOP - North Shore University Hospital
Manhasset New York 11030 United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse New York 13057 United States
Comprehensive Cancer Center at Maimonides Medical Center
Brooklyn New York 11219 United States
Elmhurst Hospital Center
Elmhurst New York 11373 United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York 10032 United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York 14642 United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook New York 11794 United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx New York 10466 United States
Memorial Sloan-Kettering Cancer Center
New York New York 10021 United States
Mount Sinai Medical Center
New York New York 10029 United States
Mount Sinai School of Medicine
New York New York 10029 United States
New York Medical College
Valhalla New York 10595 United States
New York Weill Cornell Cancer Center at Cornell University
New York New York 10021 United States
North Shore University Hospital
Manhasset New York 11030 United States
NYU Cancer Institute at New York University Medical Center
New York New York 10016 United States
Queens Cancer Center of Queens Hospital
Jamaica New York 11432 United States
Roswell Park Cancer Institute
Buffalo New York 14263-0001 United States
Schneider Children's Hospital
New Hyde Park New York 11042 United States
SUNY Downstate Medical Center
Brooklyn New York 11203 United States
SUNY Upstate Medical University Hospital
Syracuse New York 13210 United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York 14215 United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York 13210 United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina 28232-2861 United States
Cape Fear Valley Medical Center
Fayetteville North Carolina 28302-2000 United States
CCOP - Southeast Cancer Control Consortium
Goldsboro North Carolina 27534-9479 United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst North Carolina 28374 United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina 27157-1082 United States
Duke Comprehensive Cancer Center
Durham North Carolina 27710 United States
Lenoir Memorial Cancer Center
Kinston North Carolina 28503-1678 United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville North Carolina 27858-4354 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina 27599-7295 United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina 27599 United States
Mission Hospitals
Asheville North Carolina 28801 United States
NorthEast Oncology Associates - Concord
Concord North Carolina 28025 United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina 28233 United States
Veterans Affairs Medical Center - Asheville
Asheville North Carolina 28805-9913 United States
Veterans Affairs Medical Center - Durham
Durham North Carolina 27705 United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington North Carolina 28402-9025 United States
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo North Dakota 58103-4940 United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio 43210-1240 United States
CCOP - Columbus
Columbus Ohio 43206 United States
CCOP - Dayton
Dayton Ohio 45429 United States
CCOP - Toledo Community Hospital
Toledo Ohio 43623-3456 United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio 45267-0501 United States
Children's Hospital Medical Center of Akron
Akron Ohio 44308-1062 United States
Children's Medical Center - Dayton
Dayton Ohio 45404 United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio 45229-3039 United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio 44195-9001 United States
Columbus Children's Hospital
Columbus Ohio 43205-2696 United States
Forum Health-Tod Childrens Hospital
Youngstown Ohio 44501 United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio 44109 United States
St. Vincent Mercy Medical Center
Toledo Ohio 43608 United States
Toledo Children's Hospital
Toledo Ohio 43601 United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio 45220-2288 United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio 45428-1002 United States
Children's Hospital at Oklahoma University Medical Center
Oklahoma City Oklahoma 73104 United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma 74136 United States
Oklahoma University Medical Center
Oklahoma City Oklahoma 73104 United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma 73104 United States
Cancer Institute at Oregon Health and Science University
Portland Oregon 97201-3098 United States
CCOP - Columbia River Oncology Program
Portland Oregon 97225 United States
Doernbecher Children's Hospital at Oregon Health & Science University
Portland Oregon 97239-3098 United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon 97227 United States
Veterans Affairs Medical Center - Portland
Portland Oregon 97207 United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania 17822-2001 United States
Children's Hospital at Milton S. Hershey Medical Center
Hershey Pennsylvania 17033 United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania 19104 United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania 15213 United States
Geisinger Medical Center
Danville Pennsylvania 17822-1320 United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania 15236 United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania 17033-0850 United States
St. Christopher's Hospital for Children
Philadelphia Pennsylvania 19134-1095 United States
Miriam Hospital at Lifespan
Providence Rhode Island 02903 United States
CCOP - Greenville
Greenville South Carolina 29615 United States
CCOP - Upstate Carolina
Spartanburg South Carolina 29303 United States
Children's Hospital of Greenville Hospital System
Greenville South Carolina 29605 United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina 29425 United States
Palmetto Health South Carolina Cancer Center
Columbia South Carolina 29203 United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina 29401-5799 United States
Avera Cancer Institute
Sioux Falls South Dakota 57105-1080 United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota 57104 United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota 57117-5039 United States
East Tennessee Children's Hospital
Knoxville Tennessee 37901 United States
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City Tennessee 37614-0622 United States
St. Jude Children's Research Hospital
Memphis Tennessee 38105-2794 United States
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis Tennessee 38104 United States
Vanderbilt Children's Hospital
Nashville Tennessee 37232-6307 United States
Baylor College of Medicine
Houston Texas 77030 United States
Brooke Army Medical Center
Fort Sam Houston Texas 78234-6200 United States
CCOP - Scott and White Hospital
Temple Texas 76508 United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple Texas 76508 United States
Children's Hospital of Austin
Austin Texas 78701 United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas 76104 United States
Covenant Children's Hospital
Lubbock Texas 79410 United States
Harrington Cancer Center
Amarillo Texas 79106 United States
MBCCOP - South Texas Pediatrics
San Antonio Texas 78229-3900 United States
MD Anderson Cancer Center at University of Texas
Houston Texas 77030-4009 United States
Medical City Dallas Hospital
Dallas Texas 75230 United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio Texas 78229-3902 United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base Texas 78236 United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas 75390-9063 United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo Texas 79106 United States
University of Texas Health Science Center at San Antonio
San Antonio Texas 78229-3900 United States
University of Texas Medical Branch
Galveston Texas 77555-0361 United States
Veterans Affairs Medical Center - Amarillo
Amarillo Texas 79106 United States
Veterans Affairs Medical Center - Dallas
Dallas Texas 75219 United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas 78229 United States
Veterans Affairs Medical Center - Temple
Temple Texas 76504 United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah 84112 United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah 84148 United States
Vermont Cancer Center at University of Vermont
Burlington Vermont 05401-3498 United States
Cancer Center at the University of Virginia
Charlottesville Virginia 22908 United States
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke Virginia 24029 United States
Children's Hospital of the King's Daughters
Norfolk Virginia 23507 United States
INOVA Fairfax Hospital
Falls Church Virginia 22042-3300 United States
Martha Jefferson Hospital
Charlottesville Virginia 22902 United States
Massey Cancer Center at Virginia Commonwealth University
Richmond Virginia 23298-0121 United States
MBCCOP - Massey Cancer Center
Richmond Virginia 23298-0037 United States
Naval Medical Center, Portsmouth
Portsmouth Virginia 23708-5100 United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke Virginia 24014 United States
Virginia Oncology Associates - Norfolk
Norfolk Virginia 23502 United States
CCOP - Northwest
Tacoma Washington 98405-0986 United States
CCOP - Virginia Mason Research Center
Seattle Washington 98101 United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington 98105 United States
Deaconess Medical Center
Spokane Washington 99210-0248 United States
Fred Hutchinson Cancer Research Center
Seattle Washington 98109-1024 United States
Group Health Central Hospital
Seattle Washington 98112 United States
Madigan Army Medical Center
Tacoma Washington 98431-0001 United States
Mary Bridge Children's Hospital and Health Center
Tacoma Washington 98415-0299 United States
Puget Sound Oncology Consortium
Seattle Washington 98109 United States
Veterans Affairs Medical Center - Seattle
Seattle Washington 98108 United States
Cabell Huntington Hospital
Huntington West Virginia 25701 United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown West Virginia 26506-9300 United States
St. Mary's Medical Center
Huntington West Virginia 25701 United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia 25302 United States
Bellin Memorial Hospital
Green Bay Wisconsin 54301 United States
CCOP - Marshfield Clinic Research Foundation
Marshfield Wisconsin 54449 United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin 54301 United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin 54601 United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin 54449-5772 United States
Midwest Children's Cancer Center
Milwaukee Wisconsin 53226 United States
St. Vincent Hospital
Green Bay Wisconsin 54307-9070 United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin 53792-6164 United States
Children's Hospital at Westmead
Westmead New South Wales 2145 Australia
Sydney Children's Hospital
Randwick New South Wales 2031 Australia
Royal Children's Hospital
Brisbane Queensland 4029 Australia
Women's and Children's Hospital
North Adelaide South Australia 5006 Australia
Royal Children's Hospital
Parkville Victoria 3052 Australia
Princess Margaret Hospital for Children
Perth Western Australia 6001 Australia
Alberta Children's Hospital
Calgary Alberta T2T 5C7 Canada
Cross Cancer Institute
Edmonton Alberta T6G 1Z2 Canada
Lethbridge Cancer Clinic
Lethbridge Alberta T1J 1W5 Canada
Tom Baker Cancer Centre - Calgary
Calgary Alberta T2N 4N2 Canada
British Columbia Children's Hospital
Vancouver British Columbia V6H 3V4 Canada
Prostate Centre at Vancouver General Hospital
Vancouver British Columbia V5Z 3J5 Canada
Providence Health Care - Vancouver
Vancouver British Columbia V6Z 1Y6 Canada
CancerCare Manitoba
Winnipeg Manitoba R3E 0V9 Canada
Doctor Leon Richard Oncology Centre
Moncton New Brunswick E1C 8X3 Canada
Moncton Hospital
Moncton New Brunswick E1C 6ZB Canada
Saint John Regional Hospital
Saint John New Brunswick E2L 4L2 Canada
Janeway Children's Health and Rehabilitation Centre
St. John's Newfoundland and Labrador A1B 3V6 Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns Newfoundland and Labrador A1B 3V6 Canada
IWK Health Centre
Halifax Nova Scotia B3J 3G9 Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax Nova Scotia B3H 2Y9 Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor Ontario N8W 2X3 Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario N6A 4L6 Canada
Cancer Centre of Southeastern Ontario
Kingston Ontario K7L 5P9 Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario K1H 8L1 Canada
Children's Hospital of Western Ontario
London Ontario N6C 2V5 Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa Ontario L1G 2B9 Canada
Hamilton and District Urology Research Group
Hamilton Ontario L8N 1T8 Canada
Hospital for Sick Children
Toronto Ontario M5G 1X8 Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines Ontario L2R 5K3 Canada
Humber River Regional Hospital - Weston
Weston Ontario M9N 1N8 Canada
London Health Sciences Centre
London Ontario N6A 4G5 Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario L8N 3Z5 Canada
Mount Sinai Hospital - Toronto
Toronto Ontario M5G 1X5 Canada
North York General Hospital, Ontario
North York Ontario M2K 1E1 Canada
Northeastern Ontario Regional Cancer Centre
Sudbury Ontario P3E 5J1 Canada
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa Ontario K1H 1C4 Canada
Peterborough Oncology Clinic
Peterborough Ontario K9H 7B6 Canada
Princess Margaret Hospital
Toronto Ontario M5G 2M9 Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay Ontario P7B 6V4 Canada
Royal Victoria Hospital of Barrie
Barrie Ontario L4M 6M2 Canada
Scarborough Hospital - General Site
Scarborough Ontario M1P 2V5 Canada
Southlake Regional Health Centre
Newmarket Ontario L3Y 2P9 Canada
St. Joseph's Health Centre - Toronto
Toronto Ontario M6R 1B5 Canada
St. Michael's Hospital - Toronto
Toronto Ontario M5B 1W8 Canada
Sunnybrook and Women's College Health Sciences Centre
North York Ontario M4N 3M5 Canada
Toronto East General Hospital
Toronto Ontario M4C 3E7 Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario M4N 3M5 Canada
Trillium Health Centre - Mississauga
Mississauga Ontario L5B 1B8 Canada
William Osler Health Centre
Brampton Ontario L6W 2Z8 Canada
Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
Charlottetown Prince Edward Island C1A 8T5 Canada
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy Quebec GIV 4G2 Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec (P.Q.) H2X 3J4 Canada
Centre Hospitalier Regional de Lanaudiere
Joliette Quebec J6E 6J2 Canada
Hopital Charles Lemoyne
Greenfield Park Quebec J4V 2H1 Canada
Hopital Du Sacre-Coeur de Montreal
Montreal Quebec H4J 1C5 Canada
Hopital du Saint-Sacrement, Quebec
Quebec City Quebec G1S 4L8 Canada
Hopital Sainte Justine
Montreal Quebec H3T 1C5 Canada
Hotel Dieu de Montreal
Montreal Quebec H2W 1T8 Canada
L'Hopital Laval
Ste-Foy Quebec G1V 4G5 Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec H1T 2M4 Canada
Montreal Children's Hospital at McGill University Health Center
Montreal Quebec H3G 1A4 Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina Saskatchewan S4T 7T1 Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan S7N 4H4 Canada
University Medical Center Groningen
Groningen 9700 RB Netherlands
Starship Children's Health
Auckland New Zealand
Instituto de Enfermedades Neoplasicas
Lima 34 Peru
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan 00936-5067 Puerto Rico
San Jorge Children's Hospital
Santurce 00912 Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern CH 3010 Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva CH 1211 Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne CH 1011 Switzerland
Overall Clinical Trial Officials and Contacts
Bayard L. Powell, MD Study Chair Wake Forest University
Related Publications
References
Dvorak CC, Agarwal R, Dahl GV, Gregory JJ, Feusner JH. Hematopoietic stem cell transplant for pediatric acute promyelocytic leukemia. Biol Blood Marrow Transplant. 2008 Jul;14(7):824-30.
Paietta E, Goloubeva O, Neuberg D, Bennett JM, Gallagher R, Racevskis J, Dewald G, Wiernik PH, Tallman MS; Eastern Cooperative Oncology Group. A surrogate marker profile for PML/RAR alpha expressing acute promyelocytic leukemia and the association of immunophenotypic markers with morphologic and molecular subtypes. Cytometry. 2004 May;59B(1):1-9.
Paietta E, Goloubeva O, Bennett JM, et al.: A surrogate marker profile for acute promyelocytic leukemia (APL) and the association of immunophenotypic markers with morphologic and molecular subtypes of APL. [Abstract] Blood 100 (11 pt 2): A-4434, 2002.
Citations Reporting Results
Powell BL, Moser B, Stock W, et al.: Effect of consolidation with arsenic trioxide (As2O3) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710. [Abstract] J Clin Oncol 25 (Suppl 18): A-2, 2007.
Gallagher RE, Schachter-Tokarz EL, Moser BK, et al.: Frequent PML-RARα mutations in relapse patients on acute promyelocytic leukemia (APL) intergroup phase III trial C9710. [Abstract] Blood 108 (11): A-2342, 2006.
Powell BL, Moser B, Stock W, et al.: Preliminary results from the North American Acute Promyelocytic Leukemia (APL) study C9710. [Abstract] Blood 108 (11): A-566, 2006.
Stock W, Harvey R, Moser B, et al.: Minimal residual disease (MRD) and risk of relapse in acute promyelocytic leukemia (APL): insights from the North American Intergroup phase III trial C9710. [Abstract] Blood 108 (11): A-494, 2006.
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003934
Study ID Number: CDR0000067126
ClinicalTrials.gov Identifier: NCT00003934
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
