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

19. februar 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Leukemi

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

350

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Sikkerhet
Fullstendig remisjonsrate

Sekundære resultatmål

Resultatmål
Gjennomførbarhet
Effect of karyotypic abnormalities

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2003

Primær fullføring (Faktiske)

1. september 2006

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

3. oktober 2003

Først innsendt som oppfylte QC-kriteriene

6. oktober 2003

Først lagt ut (Anslag)

7. oktober 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .