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

19 février 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Leucémie

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

350

Phase

Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Masquage: Aucun (étiquette ouverte)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Sécurité
Taux de rémission complète

Mesures de résultats secondaires

Mesure des résultats
Faisabilité
Effect of karyotypic abnormalities

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Children's Oncology Group

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

Chaise d'étude: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2003

Achèvement primaire (Réel)

1 septembre 2006

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

3 octobre 2003

Première soumission répondant aux critères de contrôle qualité

6 octobre 2003

Première publication (Estimation)

7 octobre 2003

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

20 février 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .