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

19. února 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Leukémie

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

350

Fáze

Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Maskování: Žádné (otevřený štítek)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Bezpečnost
Míra úplné remise

Sekundární výstupní opatření

Měření výsledku
Proveditelnost
Effect of karyotypic abnormalities

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's Oncology Group

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. prosince 2003

Primární dokončení (Aktuální)

1. září 2006

Dokončení studie (Aktuální)

1. prosince 2013

Termíny zápisu do studia

První předloženo

3. října 2003

První předloženo, které splnilo kritéria kontroly kvality

6. října 2003

První zveřejněno (Odhad)

7. října 2003

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

20. února 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. února 2014

Naposledy ověřeno

1. února 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .