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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 - Article


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Mequinol/Tretinoin Topical

mequinol and tretinoin; Solage 




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.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
National Cancer Institute of Canada
Southwest Oncology Group
Children's Oncology Group
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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:

Endocrine therapy:

  • Prior corticosteroids allowed

Radiotherapy:

  • No concurrent palliative radiotherapy

Surgery:

  • Not specified

Other:


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.

Study ID Numbers:  CDR0000067126; CALGB-C9710; CAN-NCIC-AL.3; COG-C9710; ECOG-C9710; SWOG-C9710; CAN-NCIC-C9710; NCT00003934
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003934
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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