Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
19 de febrero de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
350
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
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
-
-
-
-
Alberta
-
Calgary, Alberta, Canadá, T2T 5C7
- Alberta Children's Hospital
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V6H 3V4
- Children's & Women's Hospital of British Columbia
-
-
Manitoba
-
Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canadá, B3K 6R8
- IWK Health Centre
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
-
-
Quebec
-
Montreal, Quebec, Canadá, H3T 1C5
- Hopital Sainte Justine
-
Montreal, Quebec, Canadá, H3H 1P3
- McGill Cancer Centre at McGill University
-
Ste-Foy, Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
-
-
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294
- Comprehensive Cancer Center at University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85016-7710
- Phoenix Children's Hospital
-
-
Arkansas
-
Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Downey, California, Estados Unidos, 90242-2814
- Southern California Permanente Medical Group
-
Loma Linda, California, Estados Unidos, 92354-2870
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Long Beach, California, Estados Unidos, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
-
Los Angeles, California, Estados Unidos, 90027
- Children's Hospital Los Angeles
-
Los Angeles, California, Estados Unidos, 90048-1865
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
-
Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
-
Oakland, California, Estados Unidos, 94609-1809
- Children's Hospital and Research Center - Oakland
-
Orange, California, Estados Unidos, 92668
- Children's Hospital of Orange County
-
Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
-
Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Oakland
-
Sacramento, California, Estados Unidos, 95819
- Sutter Cancer Center
-
San Diego, California, Estados Unidos, 92123-4282
- Children's Hospital and Health Center - San Diego
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80218-1088
- Children's Hospital Cancer Center
-
-
Connecticut
-
Hartford, Connecticut, Estados Unidos, 06106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
-
-
Delaware
-
Wilmington, Delaware, Estados Unidos, 19899
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
-
Washington, District of Columbia, Estados Unidos, 20007-2197
- Lombardi Cancer Center at Georgetown University Medical Center
-
-
Florida
-
Ft. Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center Cancer Center
-
Ft. Myers, Florida, Estados Unidos, 33908
- Lee Cancer Care of Lee Memorial Health System
-
Gainesville, Florida, Estados Unidos, 32610
- University of Florida Shands Cancer Center
-
Hollywood, Florida, Estados Unidos, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
-
Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
-
Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
-
Miami, Florida, Estados Unidos, 33176
- Baptist-South Miami Regional Cancer Program
-
Miami, Florida, Estados Unidos, 33101
- University of Miami Sylvester Comprehensive Cancer Center
-
Orlando, Florida, Estados Unidos, 32806
- M.D. Anderson Cancer Center - Orlando
-
Orlando, Florida, Estados Unidos, 32804
- Florida Hospital Cancer Institute at Florida Hospital Orlando
-
Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
-
St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
-
Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Cancer Institute at St. Joseph's Hospital
-
West Palm Beach, Florida, Estados Unidos, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
-
Savannah, Georgia, Estados Unidos, 31404-6283
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos, 95813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise, Idaho, Estados Unidos, 83712-6297
- St. Luke's Mountain States Tumor Institute - Boise
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
-
Chicago, Illinois, Estados Unidos, 60637-1463
- University of Chicago Cancer Research Center
-
Park Ridge, Illinois, Estados Unidos, 60068-1174
- Lutheran General Cancer Care Center
-
Springfield, Illinois, Estados Unidos, 62794-9230
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Indianapolis Hospital
-
Indianapolis, Indiana, Estados Unidos, 46202-5225
- Indiana University Cancer Center
-
-
Iowa
-
Iowa City, Iowa, Estados Unidos, 52242-1083
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kansas
-
Wichita, Kansas, Estados Unidos, 67214
- Wesley Medical Center
-
Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40506
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
Louisville, Kentucky, Estados Unidos, 40202-1822
- Kosair Children's Hospital
-
-
Maine
-
Bangor, Maine, Estados Unidos, 04401
- CancerCare of Maine at Eastern Maine Medial Center
-
Scarborough, Maine, Estados Unidos, 04074-9308
- Maine Children's Cancer Program
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
-
Baltimore, Maryland, Estados Unidos, 21287-5001
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109-0238
- C.S. Mott Children's Hospital at University of Michigan
-
Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Institute
-
East Lansing, Michigan, Estados Unidos, 48824-1313
- Breslin Cancer Center at Ingham Regional Medical Center
-
Grand Rapids, Michigan, Estados Unidos, 49503-2560
- Spectrum Health Cancer Care - Butterworth Campus
-
Grosse Point Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Kalamazoo, Michigan, Estados Unidos, 49007-5341
- CCOP - Kalamazoo
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
-
Minneapolis, Minnesota, Estados Unidos, 55455-0392
- Fairview University Medical Center - University Campus
-
Rochester, Minnesota, Estados Unidos, 55905-0001
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
-
Keesler AFB, Mississippi, Estados Unidos, 39534-2511
- Keesler Medical Center - Keesler Air Force Base
-
-
Missouri
-
Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
-
St. Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
St. Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68114-4113
- Children's Hospital of Omaha
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89109-2306
- Sunrise Hospital and Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
-
Livingston, New Jersey, Estados Unidos, 07039
- St. Barnabas Medical Center
-
New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
Newark, New Jersey, Estados Unidos, 07112-2094
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87131-0001
- University of New Mexico Cancer Research and Treatment Center
-
-
New York
-
Bronx, New York, Estados Unidos, 10467
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Brooklyn, New York, Estados Unidos, 11219
- Maimonides Medical Center
-
Brooklyn, New York, Estados Unidos, 11201-5493
- Brooklyn Hospital Center
-
Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
-
Mineola, New York, Estados Unidos, 11501
- Winthrop University Hospital
-
New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hospital
-
New York, New York, Estados Unidos, 10032-1537
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
-
Valhalla, New York, Estados Unidos, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, Estados Unidos, 28801-4690
- Mission Hospitals - Memorial Campus
-
Chapel Hill, North Carolina, Estados Unidos, 27599-7220
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Charlotte, North Carolina, Estados Unidos, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
-
Charlotte, North Carolina, Estados Unidos, 28232
- Blumenthal Cancer Center at Carolinas Medical Center
-
Greenville, North Carolina, Estados Unidos, 27834
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
-
Winston-Salem, North Carolina, Estados Unidos, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
-
-
Ohio
-
Akron, Ohio, Estados Unidos, 44308-1062
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, Estados Unidos, 44106-5000
- Rainbow Babies and Children's Hospital
-
Cleveland, Ohio, Estados Unidos, 44195-5217
- Cleveland Clinic Taussig Cancer Center
-
Columbus, Ohio, Estados Unidos, 43205-2696
- Columbus Children's Hospital
-
Dayton, Ohio, Estados Unidos, 45404-1815
- Children's Medical Center - Dayton
-
Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
-
Toledo, Ohio, Estados Unidos, 43608
- Medical College of Ohio Cancer Institute
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Medical Center
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97201-3098
- Cancer Institute at Oregon Health and Science University
-
-
Pennsylvania
-
Danville, Pennsylvania, Estados Unidos, 17822-1320
- Geisinger Medical Center
-
Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Estados Unidos, 19104-9786
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Estados Unidos, 19134
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213-2583
- Children's Hospital of Pittsburgh
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
Columbia, South Carolina, Estados Unidos, 29203-6897
- Palmetto Health South Carolina Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232-6310
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
Austin, Texas, Estados Unidos, 78701
- Children's Hospital of Austin
-
Corpus Christi, Texas, Estados Unidos, 78411-1721
- Driscoll Children's Hospital
-
Dallas, Texas, Estados Unidos, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Estados Unidos, 78229-3993
- Methodist Children's Hospital of South Texas
-
San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84113-1100
- Primary Children's Medical Center
-
-
Vermont
-
Burlington, Vermont, Estados Unidos, 05405
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
-
Fairfax, Virginia, Estados Unidos, 22031
- Inova Fairfax Hospital
-
Richmond, Virginia, Estados Unidos, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke, Virginia, Estados Unidos, 24029
- Carilion Cancer Center of Western Virginia
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Spokane, Washington, Estados Unidos, 99220-2555
- Providence Cancer Center at Sacred Heart Medical Center
-
Tacoma, Washington, Estados Unidos, 98431
- Madigan Army Medical Center
-
Tacoma, Washington, Estados Unidos, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
-
West Virginia
-
Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Estados Unidos, 25701
- Cabell Huntington Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, Estados Unidos, 54301
- St. Vincent Hospital
-
La Crosse, Wisconsin, Estados Unidos, 54601-5429
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Estados Unidos, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
-
-
-
-
-
Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
-
-
-
-
Chihuahua
-
Bern, Chihuahua, Suiza, 3010
- Swiss Pediatric Oncology Group Bern
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
Newly diagnosed primary acute myeloid leukemia (AML)
- At least 20% bone marrow blasts
Meets the customary FAB criteria for AML
- Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts
- Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above
- Previously untreated disease
- No promyelocytic leukemia (FAB M3)
- No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)
- No juvenile myelomonocytic leukemia
- No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
- No Down syndrome
PATIENT CHARACTERISTICS:
Age
- 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed
Performance status
- Karnofsky 50-100% (over 16 years of age) OR
- Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- No inadequate liver function
Renal
- No inadequate renal function
- No hyperuricemia (greater than 8.0 mg/dL)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR
- Creatinine no greater than 1.5 times normal
Cardiovascular
- Shortening fraction at least 27% by echocardiogram OR
- Ejection fraction at least 50% by MUGA
Pulmonary
- No proven or suspected pneumonia
Other
- Not pregnant or nursing
- No proven or suspected sepsis or meningitis
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis
Endocrine therapy
- Prior topical and inhalation steroids allowed
- No concurrent steroids as antiemetics
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Other
- No prior antileukemic therapy
- No concurrent pressor agent or ventilatory support unless approved by the study chair
- No concurrent participation in another COG therapeutic study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
|---|
|
La seguridad
|
|
Tasa de remisión completa
|
Medidas de resultado secundarias
Medida de resultado |
|---|
|
Factibilidad
|
|
Effect of karyotypic abnormalities
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Janet Franklin, MD, MPH, Children's Hospital Los Angeles
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.
- Pollard JA, Alonzo TA, Loken M, Gerbing RB, Ho PA, Bernstein ID, Raimondi SC, Hirsch B, Franklin J, Walter RB, Gamis A, Meshinchi S. Correlation of CD33 expression level with disease characteristics and response to gemtuzumab ozogamicin containing chemotherapy in childhood AML. Blood. 2012 Apr 19;119(16):3705-11. doi: 10.1182/blood-2011-12-398370. Epub 2012 Feb 29.
- Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14.
- Ho PA, Kuhn J, Gerbing RB, Pollard JA, Zeng R, Miller KL, Heerema NA, Raimondi SC, Hirsch BA, Franklin JL, Lange B, Gamis AS, Alonzo TA, Meshinchi S. WT1 synonymous single nucleotide polymorphism rs16754 correlates with higher mRNA expression and predicts significantly improved outcome in favorable-risk pediatric acute myeloid leukemia: a report from the children's oncology group. J Clin Oncol. 2011 Feb 20;29(6):704-11. doi: 10.1200/JCO.2010.31.9327. Epub 2010 Dec 28.
- Ho PA, Alonzo TA, Kopecky KJ, Miller KL, Kuhn J, Zeng R, Gerbing RB, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Reaman GH, Baker LH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Molecular alterations of the IDH1 gene in AML: a Children's Oncology Group and Southwest Oncology Group study. Leukemia. 2010 May;24(5):909-13. doi: 10.1038/leu.2010.56. Epub 2010 Apr 8.
- Ho PA, Zeng R, Alonzo TA, Gerbing RB, Miller KL, Pollard JA, Stirewalt DL, Heerema NA, Raimondi SC, Hirsch B, Franklin JL, Lange B, Meshinchi S. Prevalence and prognostic implications of WT1 mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2010 Aug 5;116(5):702-10. doi: 10.1182/blood-2010-02-268953. Epub 2010 Apr 22.
- Phillips CL, Gerbing R, Alonzo T, Perentesis JP, Harley IT, Meshinchi S, Bhatla D, Radloff G, Davies SM. MDM2 polymorphism increases susceptibility to childhood acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Aug;55(2):248-53. doi: 10.1002/pbc.22519.
- Pollard JA, Alonzo TA, Gerbing RB, Ho PA, Zeng R, Ravindranath Y, Dahl G, Lacayo NJ, Becton D, Chang M, Weinstein HJ, Hirsch B, Raimondi SC, Heerema NA, Woods WG, Lange BJ, Hurwitz C, Arceci RJ, Radich JP, Bernstein ID, Heinrich MC, Meshinchi S. Prevalence and prognostic significance of KIT mutations in pediatric patients with core binding factor AML enrolled on serial pediatric cooperative trials for de novo AML. Blood. 2010 Mar 25;115(12):2372-9. doi: 10.1182/blood-2009-09-241075. Epub 2010 Jan 7.
- Berman JN, Gerbing RB, Sung L, et al.: Prevalence and clinical implications of N-RAS mutations in childhood AML - A report from the Children's Oncology Group. [Abstract] Blood 114 (22): A-3115, 2009.
- Ho PA, Alonzo TA, Gerbing RB, Pollard J, Stirewalt DL, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Radich JP, Meshinchi S. Prevalence and prognostic implications of CEBPA mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2009 Jun 25;113(26):6558-66. doi: 10.1182/blood-2008-10-184747. Epub 2009 Mar 20.
- Sung L, Alonzo TA, Gerbing RB, Aplenc R, Lange BJ, Woods WG, Feusner J, Franklin J, Patterson MJ, Gamis AS; Children's Oncology Group. Respiratory syncytial virus infections in children with acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Dec;51(6):784-6. doi: 10.1002/pbc.21710.
- Pollard J, Alonzo T, Gerbing R, et al.: Prevalence and prognostic significance of c-KIT mutations in pediatric CBF AML patients enrolled on serial CCG/COG protocols. [Abstract] Blood 110 (11): A-1442, 2007.
- Cooper TM, Franklin J, Gerbing RB, Alonzo TA, Hurwitz C, Raimondi SC, Hirsch B, Smith FO, Mathew P, Arceci RJ, Feusner J, Iannone R, Lavey RS, Meshinchi S, Gamis A. AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: a report from the Children's Oncology Group. Cancer. 2012 Feb 1;118(3):761-9. doi: 10.1002/cncr.26190. Epub 2011 Jul 15.
- Gudgeon CJ, Harrington KH, Laszlo GS, Alonzo TA, Gerbing RB, Gamis AS, Raimondi SC, Hirsch BA, Meshinchi S, Walter RB. High expression of neutrophil elastase predicts improved survival in pediatric acute myeloid leukemia: a report from the Children's Oncology Group. Leuk Lymphoma. 2013 Jan;54(1):202-4. doi: 10.3109/10428194.2012.700480. Epub 2012 Jul 9. No abstract available.
- Loken MR, Alonzo TA, Pardo L, Gerbing RB, Raimondi SC, Hirsch BA, Ho PA, Franklin J, Cooper TM, Gamis AS, Meshinchi S. Residual disease detected by multidimensional flow cytometry signifies high relapse risk in patients with de novo acute myeloid leukemia: a report from Children's Oncology Group. Blood. 2012 Aug 23;120(8):1581-8. doi: 10.1182/blood-2012-02-408336. Epub 2012 May 30.
- Ho PA, Kutny MA, Alonzo TA, Gerbing RB, Joaquin J, Raimondi SC, Gamis AS, Meshinchi S. Leukemic mutations in the methylation-associated genes DNMT3A and IDH2 are rare events in pediatric AML: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Aug;57(2):204-9. doi: 10.1002/pbc.23179. Epub 2011 Apr 18.
- Walter RB, Alonzo TA, Gerbing RB, Ho PA, Smith FO, Raimondi SC, Hirsch BA, Gamis AS, Franklin JL, Hurwitz CA, Loken MR, Meshinchi S. High expression of the very late antigen-4 integrin independently predicts reduced risk of relapse and improved outcome in pediatric acute myeloid leukemia: a report from the children's oncology group. J Clin Oncol. 2010 Jun 10;28(17):2831-8. doi: 10.1200/JCO.2009.27.5693. Epub 2010 Apr 26.
- Walter RB, Alonzo TA, Gerbing RB, et al.: High expression of the very late antigen (VLA)-4 (CD49d) integrin predicts for reduced risk of relapse and better outcome in pediatric acute myeloid leukemia (AML): A report from the Children's Oncology Group. [Abstract] Blood 114 (22): A-1592, 2009.
- Franklin J, Alonzo T, Hurwitz CA, et al.: COG AAML03P1: efficacy and safety in a pilot study of intensive chemotherapy including gemtuzumab in children newly diagnosed with acute myeloid leukemia (AML). [Abstract] Blood 112 (11): A- 136, 2008.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2003
Finalización primaria (Actual)
1 de septiembre de 2006
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
3 de octubre de 2003
Primero enviado que cumplió con los criterios de control de calidad
6 de octubre de 2003
Publicado por primera vez (Estimar)
7 de octubre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
19 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
- eritroleucemia aguda infantil (M6)
- leucemia megacariocítica aguda infantil (M7)
- leucemia mieloide mínimamente diferenciada aguda infantil (M0)
- leucemia mieloide aguda infantil no tratada y otras neoplasias malignas mieloides
- leucemia mieloblástica aguda infantil sin maduración (M1)
- leucemia mieloblástica aguda infantil con maduración (M2)
- leucemia mielomonocítica aguda infantil (M4)
- leucemia monoblástica aguda infantil (M5a)
- leucemia monocítica aguda infantil (M5b)
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Leucemia
- Leucemia Mieloide
- Leucemia Mieloide Aguda
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes del sistema nervioso periférico
- Agentes Antivirales
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Agentes dermatológicos
- Antibióticos, Antineoplásicos
- Agentes antifúngicos
- Agentes de control reproductivo
- Agentes abortivos, no esteroideos
- Agentes abortivos
- Antagonistas del ácido fólico
- Inhibidores de calcineurina
- Ciclofosfamida
- Etopósido
- Citarabina
- Metotrexato
- Daunorrubicina
- Asparaginasa
- Mitoxantrona
- Busulfán
- Ciclosporina
- Ciclosporinas
- Gemtuzumab
Otros números de identificación del estudio
- AAML03P1
- CDR0000330133 (Otro identificador: Clinical Trials.gov)
- COG-AAML03P1 (Otro identificador: Children's Oncology Group)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .