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

19 febbraio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Leucemia

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

350

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino
Adulto
Adulto più anziano

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Sicurezza
Tasso di remissione completa

Misure di risultato secondarie

Misura del risultato
Fattibilità
Effect of karyotypic abnormalities

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Children's Oncology Group

Collaboratori

National Cancer Institute (NCI)

Investigatori

Cattedra di studio: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2003

Completamento primario (Effettivo)

1 settembre 2006

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

3 ottobre 2003

Primo inviato che soddisfa i criteri di controllo qualità

6 ottobre 2003

Primo Inserito (Stima)

7 ottobre 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 febbraio 2014

Ultimo verificato

1 febbraio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .