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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Leukæmi

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

350

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Sikkerhed
Fuldstændig remissionsrate

Sekundære resultatmål

Resultatmål
Gennemførlighed
Effect of karyotypic abnormalities

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2003

Primær færdiggørelse (Faktiske)

1. september 2006

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

3. oktober 2003

Først indsendt, der opfyldte QC-kriterier

6. oktober 2003

Først opslået (Skøn)

7. oktober 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .