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Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

19 lutego 2014 zaktualizowane przez: Children's Oncology Group

Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.

Przegląd badań

Status

Zakończony

Warunki

Białaczka

Interwencja / Leczenie

Szczegółowy opis

OBJECTIVES:

Primary

Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.
Determine the complete remission rate of patients treated with this regimen.

Secondary

Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.
Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II.
Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I.
Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II.
Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III.
Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.
Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0.
Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11.

In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

350

Faza

Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital
- Queensland
  - Herston, Brisbane, Queensland, Australia, 4029
    - Office of S. David Lang
- Western Australia
  - Perth, Western Australia, Australia, 6001
    - Princess Margaret Hospital for Children
Kanada
- Alberta
  - Calgary, Alberta, Kanada, T2T 5C7
    - Alberta Children's Hospital
- British Columbia
  - Vancouver, British Columbia, Kanada, V6H 3V4
    - Children's & Women's Hospital of British Columbia
- Manitoba
  - Winnipeg, Manitoba, Kanada, R3E 0V9
    - CancerCare Manitoba
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
    - Janeway Children's Health and Rehabilitation Centre
- Nova Scotia
  - Halifax, Nova Scotia, Kanada, B3K 6R8
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, Kanada, L8N 3Z5
    - McMaster Children's Hospital at Hamilton Health Sciences
- Quebec
  - Montreal, Quebec, Kanada, H3T 1C5
    - Hôpital Sainte Justine
  - Montreal, Quebec, Kanada, H3H 1P3
    - McGill Cancer Centre at McGill University
  - Ste-Foy, Quebec, Kanada, G1V 4G2
    - Centre Hospitalier Universitaire de Quebec
Portoryko
- - Santurce, Portoryko, 00912
    - San Jorge Children's Hospital
Stany Zjednoczone
- Alabama
  - Birmingham, Alabama, Stany Zjednoczone, 35294
    - Comprehensive Cancer Center at University of Alabama at Birmingham
- Arizona
  - Phoenix, Arizona, Stany Zjednoczone, 85016-7710
    - Phoenix Children's Hospital
- Arkansas
  - Little Rock, Arkansas, Stany Zjednoczone, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Downey, California, Stany Zjednoczone, 90242-2814
    - Southern California Permanente Medical Group
  - Loma Linda, California, Stany Zjednoczone, 92354-2870
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, Stany Zjednoczone, 90801
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, Stany Zjednoczone, 90027
    - Children's Hospital Los Angeles
  - Los Angeles, California, Stany Zjednoczone, 90048-1865
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Madera, California, Stany Zjednoczone, 93638-8762
    - Children's Hospital Central California
  - Oakland, California, Stany Zjednoczone, 94609-1809
    - Children's Hospital and Research Center - Oakland
  - Orange, California, Stany Zjednoczone, 92668
    - Children's Hospital of Orange County
  - Sacramento, California, Stany Zjednoczone, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, Stany Zjednoczone, 95825
    - Kaiser Permanente Medical Center - Oakland
  - Sacramento, California, Stany Zjednoczone, 95819
    - Sutter Cancer Center
  - San Diego, California, Stany Zjednoczone, 92123-4282
    - Children's Hospital and Health Center - San Diego
- Colorado
  - Denver, Colorado, Stany Zjednoczone, 80218-1088
    - Children's Hospital Cancer Center
- Connecticut
  - Hartford, Connecticut, Stany Zjednoczone, 06106
    - Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Delaware
  - Wilmington, Delaware, Stany Zjednoczone, 19899
    - Alfred I. DuPont Hospital for Children
- District of Columbia
  - Washington, District of Columbia, Stany Zjednoczone, 20010-2970
    - Children's National Medical Center
  - Washington, District of Columbia, Stany Zjednoczone, 20007-2197
    - Lombardi Cancer Center at Georgetown University Medical Center
- Florida
  - Ft. Lauderdale, Florida, Stany Zjednoczone, 33316
    - Broward General Medical Center Cancer Center
  - Ft. Myers, Florida, Stany Zjednoczone, 33908
    - Lee Cancer Care of Lee Memorial Health System
  - Gainesville, Florida, Stany Zjednoczone, 32610
    - University of Florida Shands Cancer Center
  - Hollywood, Florida, Stany Zjednoczone, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jacksonville, Florida, Stany Zjednoczone, 32207
    - Nemours Children's Clinic
  - Miami, Florida, Stany Zjednoczone, 33155
    - Miami Children's Hospital
  - Miami, Florida, Stany Zjednoczone, 33176
    - Baptist-South Miami Regional Cancer Program
  - Miami, Florida, Stany Zjednoczone, 33101
    - University of Miami Sylvester Comprehensive Cancer Center
  - Orlando, Florida, Stany Zjednoczone, 32806
    - M.D. Anderson Cancer Center - Orlando
  - Orlando, Florida, Stany Zjednoczone, 32804
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Pensacola, Florida, Stany Zjednoczone, 32504
    - Sacred Heart Cancer Center at Sacred Heart Hospital
  - St. Petersburg, Florida, Stany Zjednoczone, 33701
    - All Children's Hospital
  - Tampa, Florida, Stany Zjednoczone, 33607
    - St. Joseph's Cancer Institute at St. Joseph's Hospital
  - West Palm Beach, Florida, Stany Zjednoczone, 33407
    - Kaplan Cancer Center at St. Mary's Medical Center
- Georgia
  - Atlanta, Georgia, Stany Zjednoczone, 30322
    - Emory University Hospital - Atlanta
  - Savannah, Georgia, Stany Zjednoczone, 31404-6283
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, Stany Zjednoczone, 95813
    - Cancer Research Center of Hawaii
- Idaho
  - Boise, Idaho, Stany Zjednoczone, 83712-6297
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Chicago, Illinois, Stany Zjednoczone, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, Stany Zjednoczone, 60637-1463
    - University of Chicago Cancer Research Center
  - Park Ridge, Illinois, Stany Zjednoczone, 60068-1174
    - Lutheran General Cancer Care Center
  - Springfield, Illinois, Stany Zjednoczone, 62794-9230
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Stany Zjednoczone, 46260
    - St. Vincent Indianapolis Hospital
  - Indianapolis, Indiana, Stany Zjednoczone, 46202-5225
    - Indiana University Cancer Center
- Iowa
  - Iowa City, Iowa, Stany Zjednoczone, 52242-1083
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Wichita, Kansas, Stany Zjednoczone, 67214
    - Wesley Medical Center
  - Wichita, Kansas, Stany Zjednoczone, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
- Kentucky
  - Lexington, Kentucky, Stany Zjednoczone, 40506
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, Stany Zjednoczone, 40202-1822
    - Kosair Children's Hospital
- Maine
  - Bangor, Maine, Stany Zjednoczone, 04401
    - CancerCare of Maine at Eastern Maine Medial Center
  - Scarborough, Maine, Stany Zjednoczone, 04074-9308
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, Stany Zjednoczone, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, Stany Zjednoczone, 21287-5001
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, Stany Zjednoczone, 02111
    - Floating Hospital for Children
- Michigan
  - Ann Arbor, Michigan, Stany Zjednoczone, 48109-0238
    - C.S. Mott Children's Hospital at University of Michigan
  - Detroit, Michigan, Stany Zjednoczone, 48201
    - Barbara Ann Karmanos Cancer Institute
  - East Lansing, Michigan, Stany Zjednoczone, 48824-1313
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Grand Rapids, Michigan, Stany Zjednoczone, 49503-2560
    - Spectrum Health Cancer Care - Butterworth Campus
  - Grosse Point Woods, Michigan, Stany Zjednoczone, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Kalamazoo, Michigan, Stany Zjednoczone, 49007-5341
    - CCOP - Kalamazoo
- Minnesota
  - Minneapolis, Minnesota, Stany Zjednoczone, 55404
    - Children's Hospitals and Clinics - Minneapolis/St. Paul
  - Minneapolis, Minnesota, Stany Zjednoczone, 55455-0392
    - Fairview University Medical Center - University Campus
  - Rochester, Minnesota, Stany Zjednoczone, 55905-0001
    - Mayo Clinic Cancer Center
- Mississippi
  - Jackson, Mississippi, Stany Zjednoczone, 39216-4505
    - University of Mississippi Medical Center
  - Keesler AFB, Mississippi, Stany Zjednoczone, 39534-2511
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Kansas City, Missouri, Stany Zjednoczone, 64108
    - Children's Mercy Hospital
  - St. Louis, Missouri, Stany Zjednoczone, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
  - St. Louis, Missouri, Stany Zjednoczone, 63104
    - Cardinal Glennon Children's Hospital
- Nebraska
  - Omaha, Nebraska, Stany Zjednoczone, 68114-4113
    - Children's Hospital of Omaha
- Nevada
  - Las Vegas, Nevada, Stany Zjednoczone, 89109-2306
    - Sunrise Hospital and Medical Center
- New Jersey
  - Hackensack, New Jersey, Stany Zjednoczone, 07601
    - Hackensack University Medical Center
  - Livingston, New Jersey, Stany Zjednoczone, 07039
    - St. Barnabas Medical Center
  - New Brunswick, New Jersey, Stany Zjednoczone, 08901
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - Newark, New Jersey, Stany Zjednoczone, 07112-2094
    - Newark Beth Israel Medical Center
  - Paterson, New Jersey, Stany Zjednoczone, 07503
    - St. Joseph's Hospital and Medical Center
- New Mexico
  - Albuquerque, New Mexico, Stany Zjednoczone, 87131-0001
    - University of New Mexico Cancer Research and Treatment Center
- New York
  - Bronx, New York, Stany Zjednoczone, 10467
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Brooklyn, New York, Stany Zjednoczone, 11219
    - Maimonides Medical Center
  - Brooklyn, New York, Stany Zjednoczone, 11201-5493
    - Brooklyn Hospital Center
  - Buffalo, New York, Stany Zjednoczone, 14263
    - Roswell Park Cancer Institute
  - Mineola, New York, Stany Zjednoczone, 11501
    - Winthrop University Hospital
  - New Hyde Park, New York, Stany Zjednoczone, 11040
    - Schneider Children's Hospital
  - New York, New York, Stany Zjednoczone, 10032-1537
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Syracuse, New York, Stany Zjednoczone, 13210
    - SUNY Upstate Medical University Hospital
  - Valhalla, New York, Stany Zjednoczone, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, Stany Zjednoczone, 28801-4690
    - Mission Hospitals - Memorial Campus
  - Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7220
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, Stany Zjednoczone, 28233
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Charlotte, North Carolina, Stany Zjednoczone, 28232
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Greenville, North Carolina, Stany Zjednoczone, 27834
    - Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  - Winston-Salem, North Carolina, Stany Zjednoczone, 27157-1081
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, Stany Zjednoczone, 58122
    - CCOP - MeritCare Hospital
- Ohio
  - Akron, Ohio, Stany Zjednoczone, 44308-1062
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Stany Zjednoczone, 45229-3039
    - Cincinnati Children's Hospital Medical Center
  - Cleveland, Ohio, Stany Zjednoczone, 44106-5000
    - Rainbow Babies and Children's Hospital
  - Cleveland, Ohio, Stany Zjednoczone, 44195-5217
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Stany Zjednoczone, 43205-2696
    - Columbus Children's Hospital
  - Dayton, Ohio, Stany Zjednoczone, 45404-1815
    - Children's Medical Center - Dayton
  - Toledo, Ohio, Stany Zjednoczone, 43606
    - Toledo Hospital
  - Toledo, Ohio, Stany Zjednoczone, 43608
    - Medical College of Ohio Cancer Institute
- Oklahoma
  - Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
    - Oklahoma University Medical Center
- Oregon
  - Portland, Oregon, Stany Zjednoczone, 97201-3098
    - Cancer Institute at Oregon Health and Science University
- Pennsylvania
  - Danville, Pennsylvania, Stany Zjednoczone, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19104-9786
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19134
    - St. Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213-2583
    - Children's Hospital of Pittsburgh
- South Carolina
  - Charleston, South Carolina, Stany Zjednoczone, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Columbia, South Carolina, Stany Zjednoczone, 29203-6897
    - Palmetto Health South Carolina Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
- Tennessee
  - Nashville, Tennessee, Stany Zjednoczone, 37232-6310
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, Stany Zjednoczone, 79106
    - Texas Tech University Health Sciences Center School of Medicine
  - Austin, Texas, Stany Zjednoczone, 78701
    - Children's Hospital of Austin
  - Corpus Christi, Texas, Stany Zjednoczone, 78411-1721
    - Driscoll Children's Hospital
  - Dallas, Texas, Stany Zjednoczone, 75390-9063
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Lubbock, Texas, Stany Zjednoczone, 79410
    - Covenant Children's Hospital
  - San Antonio, Texas, Stany Zjednoczone, 78229-3993
    - Methodist Children's Hospital of South Texas
  - San Antonio, Texas, Stany Zjednoczone, 78207
    - University of Texas Health Science Center at San Antonio
  - Temple, Texas, Stany Zjednoczone, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone, 84113-1100
    - Primary Children's Medical Center
- Vermont
  - Burlington, Vermont, Stany Zjednoczone, 05405
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Fairfax, Virginia, Stany Zjednoczone, 22031
    - INOVA Fairfax Hospital
  - Richmond, Virginia, Stany Zjednoczone, 23298-0121
    - Massey Cancer Center at Virginia Commonwealth University
  - Roanoke, Virginia, Stany Zjednoczone, 24029
    - Carilion Cancer Center of Western Virginia
- Washington
  - Seattle, Washington, Stany Zjednoczone, 98105
    - Children's Hospital and Regional Medical Center - Seattle
  - Spokane, Washington, Stany Zjednoczone, 99220-2555
    - Providence Cancer Center at Sacred Heart Medical Center
  - Tacoma, Washington, Stany Zjednoczone, 98431
    - Madigan Army Medical Center
  - Tacoma, Washington, Stany Zjednoczone, 98405
    - Mary Bridge Children's Hospital and Health Center - Tacoma
- West Virginia
  - Charleston, West Virginia, Stany Zjednoczone, 25302
    - West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  - Huntington, West Virginia, Stany Zjednoczone, 25701
    - Cabell Huntington Hospital
- Wisconsin
  - Green Bay, Wisconsin, Stany Zjednoczone, 54301
    - St. Vincent Hospital
  - La Crosse, Wisconsin, Stany Zjednoczone, 54601-5429
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Stany Zjednoczone, 53792-0001
    - University of Wisconsin Comprehensive Cancer Center
  - Milwaukee, Wisconsin, Stany Zjednoczone, 53226
    - Midwest Children's Cancer Center
Szwajcaria
- Chihuahua
  - Bern, Chihuahua, Szwajcaria, 3010
    - Swiss Pediatric Oncology Group Bern

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dziecko
Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

DISEASE CHARACTERISTICS:

Newly diagnosed primary acute myeloid leukemia (AML)
- At least 20% bone marrow blasts
- Meets the customary FAB criteria for AML
  - Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts
- Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above
Previously untreated disease
No promyelocytic leukemia (FAB M3)
No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)
No juvenile myelomonocytic leukemia
No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
No Down syndrome

PATIENT CHARACTERISTICS:

Age

1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed

Performance status

Karnofsky 50-100% (over 16 years of age) OR
Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

No inadequate liver function

Renal

No inadequate renal function
No hyperuricemia (greater than 8.0 mg/dL)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR
Creatinine no greater than 1.5 times normal

Cardiovascular

Shortening fraction at least 27% by echocardiogram OR
Ejection fraction at least 50% by MUGA

Pulmonary

No proven or suspected pneumonia

Other

Not pregnant or nursing
No proven or suspected sepsis or meningitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis

Endocrine therapy

Prior topical and inhalation steroids allowed
No concurrent steroids as antiemetics

Radiotherapy

No prior radiotherapy

Surgery

Not specified

Other

No prior antileukemic therapy
No concurrent pressor agent or ventilatory support unless approved by the study chair
No concurrent participation in another COG therapeutic study

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Maskowanie: Brak (otwarta etykieta)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Bezpieczeństwo
Całkowity odsetek remisji

Miary wyników drugorzędnych

Miara wyniku
Wykonalność
Effect of karyotypic abnormalities

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Oncology Group

Współpracownicy

National Cancer Institute (NCI)

Śledczy

Krzesło do nauki: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2003

Zakończenie podstawowe (Rzeczywisty)

1 września 2006

Ukończenie studiów (Rzeczywisty)

1 grudnia 2013

Daty rejestracji na studia

Pierwszy przesłany

3 października 2003

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 października 2003

Pierwszy wysłany (Oszacować)

7 października 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

20 lutego 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 lutego 2014

Ostatnia weryfikacja

1 lutego 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

AAML03P1
CDR0000330133 (Inny identyfikator: Clinical Trials.gov)
COG-AAML03P1 (Inny identyfikator: Children's Oncology Group)

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