Methotrexate Injection |
Amethopterin; MTX Injection |
Clinical Trial: 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
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies adult acute promyelocytic leukemia (M3) childhood acute promyelocytic leukemia (M3) adult acute myeloid leukemia with t(15;17)(q22;q12) | Drug: arsenic trioxide Drug: cytarabine Drug: daunorubicin Drug: mercaptopurine Drug: methotrexate Drug: tretinoin Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: differentiation therapy | Phase III |
MedlinePlus related topics: Bone Marrow Diseases; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Tretinoin, Cytarabine, and Daunorubicin With or Without Arsenic Trioxide as Induction/Consolidation Therapy Followed by Intermittent Tretinoin With or Without Mercaptopurine and Methotrexate as Maintenance Therapy in Patients With Previously Untreated Acute Promyelocytic Leukemia
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.
- 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.
- 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.
Eligibility
Genders Eligible for Study: Both
Criteria
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
Location Information
Alabama
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
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
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
California
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
Colorado
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
Connecticut
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
Delaware
Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19899, United States
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States
District of Columbia
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
Florida
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
Georgia
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
Hawaii
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
Idaho
Mountain States Tumor Institute - Boise, Boise, Idaho, 83712, United States
Illinois
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
Indiana
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
Iowa
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
Kansas
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
Kentucky
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
Louisiana
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
Maine
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, 04401, United States
Maine Children's Cancer Program, Scarborough, Maine, 04074-9308, United States
Maryland
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
Massachusetts
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
Michigan
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
Minnesota
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
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States
Missouri
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
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States
Nebraska
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
Nevada
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
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
New Jersey
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
New Mexico
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
New York
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
North Carolina
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
North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo, North Dakota, 58103-4940, United States
Ohio
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
Oklahoma
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
Oregon
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
Pennsylvania
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
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02903, United States
South Carolina
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
South Dakota
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
Tennessee
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
Texas
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
Utah
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
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States
Virginia
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
Washington
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
West Virginia
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
 
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
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.

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