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

19 februari 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Leukemie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

Primary

Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.
Determine the complete remission rate of patients treated with this regimen.

Secondary

Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.
Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II.
Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I.
Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II.
Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III.
Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.
Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0.
Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11.

In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

350

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Veiligheid
Volledig remissiepercentage

Secundaire uitkomstmaten

Uitkomstmaat
Geschiktheid
Effect of karyotypic abnormalities

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Children's Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2003

Primaire voltooiing (Werkelijk)

1 september 2006

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

3 oktober 2003

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2003

Eerst geplaatst (Schatting)

7 oktober 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

20 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

19 februari 2014

Laatst geverifieerd

1 februari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .