Tretinoin, Cytarabine, and Daunorubicin With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia

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.