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

2014년 2월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

백혈병

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

350

단계

2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Alabama
  - Birmingham, Alabama, 미국, 35294
    - Comprehensive Cancer Center at University of Alabama at Birmingham
- Arizona
  - Phoenix, Arizona, 미국, 85016-7710
    - Phoenix Children's Hospital
- Arkansas
  - Little Rock, Arkansas, 미국, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Downey, California, 미국, 90242-2814
    - Southern California Permanente Medical Group
  - Loma Linda, California, 미국, 92354-2870
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, 미국, 90801
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, 미국, 90027
    - Children's Hospital Los Angeles
  - Los Angeles, California, 미국, 90048-1865
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Madera, California, 미국, 93638-8762
    - Children's Hospital Central California
  - Oakland, California, 미국, 94609-1809
    - Children's Hospital and Research Center - Oakland
  - Orange, California, 미국, 92668
    - Children's Hospital of Orange County
  - Sacramento, California, 미국, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, 미국, 95825
    - Kaiser Permanente Medical Center - Oakland
  - Sacramento, California, 미국, 95819
    - Sutter Cancer Center
  - San Diego, California, 미국, 92123-4282
    - Children's Hospital and Health Center - San Diego
- Colorado
  - Denver, Colorado, 미국, 80218-1088
    - Children's Hospital Cancer Center
- Connecticut
  - Hartford, Connecticut, 미국, 06106
    - Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Delaware
  - Wilmington, Delaware, 미국, 19899
    - Alfred I. DuPont Hospital for Children
- District of Columbia
  - Washington, District of Columbia, 미국, 20010-2970
    - Children's National Medical Center
  - Washington, District of Columbia, 미국, 20007-2197
    - Lombardi Cancer Center at Georgetown University Medical Center
- Florida
  - Ft. Lauderdale, Florida, 미국, 33316
    - Broward General Medical Center Cancer Center
  - Ft. Myers, Florida, 미국, 33908
    - Lee Cancer Care of Lee Memorial Health System
  - Gainesville, Florida, 미국, 32610
    - University of Florida Shands Cancer Center
  - Hollywood, Florida, 미국, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jacksonville, Florida, 미국, 32207
    - Nemours Children's Clinic
  - Miami, Florida, 미국, 33155
    - Miami Children's Hospital
  - Miami, Florida, 미국, 33176
    - Baptist-South Miami Regional Cancer Program
  - Miami, Florida, 미국, 33101
    - University of Miami Sylvester Comprehensive Cancer Center
  - Orlando, Florida, 미국, 32806
    - M.D. Anderson Cancer Center - Orlando
  - Orlando, Florida, 미국, 32804
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Pensacola, Florida, 미국, 32504
    - Sacred Heart Cancer Center at Sacred Heart Hospital
  - St. Petersburg, Florida, 미국, 33701
    - All Children's Hospital
  - Tampa, Florida, 미국, 33607
    - St. Joseph's Cancer Institute at St. Joseph's Hospital
  - West Palm Beach, Florida, 미국, 33407
    - Kaplan Cancer Center at St. Mary's Medical Center
- Georgia
  - Atlanta, Georgia, 미국, 30322
    - Emory University Hospital - Atlanta
  - Savannah, Georgia, 미국, 31404-6283
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, 미국, 95813
    - Cancer Research Center of Hawaii
- Idaho
  - Boise, Idaho, 미국, 83712-6297
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Chicago, Illinois, 미국, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, 미국, 60637-1463
    - University of Chicago Cancer Research Center
  - Park Ridge, Illinois, 미국, 60068-1174
    - Lutheran General Cancer Care Center
  - Springfield, Illinois, 미국, 62794-9230
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, 미국, 46260
    - St. Vincent Indianapolis Hospital
  - Indianapolis, Indiana, 미국, 46202-5225
    - Indiana University Cancer Center
- Iowa
  - Iowa City, Iowa, 미국, 52242-1083
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Wichita, Kansas, 미국, 67214
    - Wesley Medical Center
  - Wichita, Kansas, 미국, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
- Kentucky
  - Lexington, Kentucky, 미국, 40506
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, 미국, 40202-1822
    - Kosair Children's Hospital
- Maine
  - Bangor, Maine, 미국, 04401
    - CancerCare of Maine at Eastern Maine Medial Center
  - Scarborough, Maine, 미국, 04074-9308
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, 미국, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, 미국, 21287-5001
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, 미국, 02111
    - Floating Hospital for Children
- Michigan
  - Ann Arbor, Michigan, 미국, 48109-0238
    - C.S. Mott Children's Hospital at University of Michigan
  - Detroit, Michigan, 미국, 48201
    - Barbara Ann Karmanos Cancer Institute
  - East Lansing, Michigan, 미국, 48824-1313
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Grand Rapids, Michigan, 미국, 49503-2560
    - Spectrum Health Cancer Care - Butterworth Campus
  - Grosse Point Woods, Michigan, 미국, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Kalamazoo, Michigan, 미국, 49007-5341
    - CCOP - Kalamazoo
- Minnesota
  - Minneapolis, Minnesota, 미국, 55404
    - Children's Hospitals and Clinics - Minneapolis/St. Paul
  - Minneapolis, Minnesota, 미국, 55455-0392
    - Fairview University Medical Center - University Campus
  - Rochester, Minnesota, 미국, 55905-0001
    - Mayo Clinic Cancer Center
- Mississippi
  - Jackson, Mississippi, 미국, 39216-4505
    - University of Mississippi Medical Center
  - Keesler AFB, Mississippi, 미국, 39534-2511
    - Keesler Medical Center - Keesler Air Force Base
- Missouri
  - Kansas City, Missouri, 미국, 64108
    - Children's Mercy Hospital
  - St. Louis, Missouri, 미국, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
  - St. Louis, Missouri, 미국, 63104
    - Cardinal Glennon Children's Hospital
- Nebraska
  - Omaha, Nebraska, 미국, 68114-4113
    - Children's Hospital of Omaha
- Nevada
  - Las Vegas, Nevada, 미국, 89109-2306
    - Sunrise Hospital and Medical Center
- New Jersey
  - Hackensack, New Jersey, 미국, 07601
    - Hackensack University Medical Center
  - Livingston, New Jersey, 미국, 07039
    - St. Barnabas Medical Center
  - New Brunswick, New Jersey, 미국, 08901
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - Newark, New Jersey, 미국, 07112-2094
    - Newark Beth Israel Medical Center
  - Paterson, New Jersey, 미국, 07503
    - St. Joseph's Hospital and Medical Center
- New Mexico
  - Albuquerque, New Mexico, 미국, 87131-0001
    - University of New Mexico Cancer Research and Treatment Center
- New York
  - Bronx, New York, 미국, 10467
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Brooklyn, New York, 미국, 11219
    - Maimonides Medical Center
  - Brooklyn, New York, 미국, 11201-5493
    - Brooklyn Hospital Center
  - Buffalo, New York, 미국, 14263
    - Roswell Park Cancer Institute
  - Mineola, New York, 미국, 11501
    - Winthrop University Hospital
  - New Hyde Park, New York, 미국, 11040
    - Schneider Children's Hospital
  - New York, New York, 미국, 10032-1537
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Syracuse, New York, 미국, 13210
    - SUNY Upstate Medical University Hospital
  - Valhalla, New York, 미국, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, 미국, 28801-4690
    - Mission Hospitals - Memorial Campus
  - Chapel Hill, North Carolina, 미국, 27599-7220
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, 미국, 28233
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Charlotte, North Carolina, 미국, 28232
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Greenville, North Carolina, 미국, 27834
    - Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  - Winston-Salem, North Carolina, 미국, 27157-1081
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, 미국, 58122
    - CCOP - MeritCare Hospital
- Ohio
  - Akron, Ohio, 미국, 44308-1062
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, 미국, 45229-3039
    - Cincinnati Children's Hospital Medical Center
  - Cleveland, Ohio, 미국, 44106-5000
    - Rainbow Babies and Children's Hospital
  - Cleveland, Ohio, 미국, 44195-5217
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, 미국, 43205-2696
    - Columbus Children's Hospital
  - Dayton, Ohio, 미국, 45404-1815
    - Children's Medical Center - Dayton
  - Toledo, Ohio, 미국, 43606
    - Toledo Hospital
  - Toledo, Ohio, 미국, 43608
    - Medical College of Ohio Cancer Institute
- Oklahoma
  - Oklahoma City, Oklahoma, 미국, 73104
    - Oklahoma University Medical Center
- Oregon
  - Portland, Oregon, 미국, 97201-3098
    - Cancer Institute at Oregon Health and Science University
- Pennsylvania
  - Danville, Pennsylvania, 미국, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, 미국, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, 미국, 19104-9786
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, 미국, 19134
    - St. Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, 미국, 15213-2583
    - Children's Hospital of Pittsburgh
- South Carolina
  - Charleston, South Carolina, 미국, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Columbia, South Carolina, 미국, 29203-6897
    - Palmetto Health South Carolina Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, 미국, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
- Tennessee
  - Nashville, Tennessee, 미국, 37232-6310
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, 미국, 79106
    - Texas Tech University Health Sciences Center School of Medicine
  - Austin, Texas, 미국, 78701
    - Children's Hospital of Austin
  - Corpus Christi, Texas, 미국, 78411-1721
    - Driscoll Children's Hospital
  - Dallas, Texas, 미국, 75390-9063
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Lubbock, Texas, 미국, 79410
    - Covenant Children's Hospital
  - San Antonio, Texas, 미국, 78229-3993
    - Methodist Children's Hospital of South Texas
  - San Antonio, Texas, 미국, 78207
    - University of Texas Health Science Center at San Antonio
  - Temple, Texas, 미국, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, 미국, 84113-1100
    - Primary Children's Medical Center
- Vermont
  - Burlington, Vermont, 미국, 05405
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Fairfax, Virginia, 미국, 22031
    - INOVA Fairfax Hospital
  - Richmond, Virginia, 미국, 23298-0121
    - Massey Cancer Center at Virginia Commonwealth University
  - Roanoke, Virginia, 미국, 24029
    - Carilion Cancer Center of Western Virginia
- Washington
  - Seattle, Washington, 미국, 98105
    - Children's Hospital and Regional Medical Center - Seattle
  - Spokane, Washington, 미국, 99220-2555
    - Providence Cancer Center at Sacred Heart Medical Center
  - Tacoma, Washington, 미국, 98431
    - Madigan Army Medical Center
  - Tacoma, Washington, 미국, 98405
    - Mary Bridge Children's Hospital and Health Center - Tacoma
- West Virginia
  - Charleston, West Virginia, 미국, 25302
    - West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  - Huntington, West Virginia, 미국, 25701
    - Cabell Huntington Hospital
- Wisconsin
  - Green Bay, Wisconsin, 미국, 54301
    - St. Vincent Hospital
  - La Crosse, Wisconsin, 미국, 54601-5429
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, 미국, 53792-0001
    - University of Wisconsin Comprehensive Cancer Center
  - Milwaukee, Wisconsin, 미국, 53226
    - Midwest Children's Cancer Center
스위스
- Chihuahua
  - Bern, Chihuahua, 스위스, 3010
    - Swiss Pediatric Oncology Group Bern
캐나다
- Alberta
  - Calgary, Alberta, 캐나다, T2T 5C7
    - Alberta Children's Hospital
- British Columbia
  - Vancouver, British Columbia, 캐나다, V6H 3V4
    - Children's & Women's Hospital of British Columbia
- Manitoba
  - Winnipeg, Manitoba, 캐나다, R3E 0V9
    - CancerCare Manitoba
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
    - Janeway Children's Health and Rehabilitation Centre
- Nova Scotia
  - Halifax, Nova Scotia, 캐나다, B3K 6R8
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, 캐나다, L8N 3Z5
    - McMaster Children's Hospital at Hamilton Health Sciences
- Quebec
  - Montreal, Quebec, 캐나다, H3T 1C5
    - Hôpital Sainte Justine
  - Montreal, Quebec, 캐나다, H3H 1P3
    - McGill Cancer Centre at McGill University
  - Ste-Foy, Quebec, 캐나다, G1V 4G2
    - Centre Hospitalier Universitaire de Quebec
푸에르토 리코
- - Santurce, 푸에르토 리코, 00912
    - San Jorge Children's Hospital
호주
- New South Wales
  - Westmead, New South Wales, 호주, 2145
    - Westmead Hospital
- Queensland
  - Herston, Brisbane, Queensland, 호주, 4029
    - Office of S. David Lang
- Western Australia
  - Perth, Western Australia, 호주, 6001
    - Princess Margaret Hospital for Children

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
안전
완전 관해율

2차 결과 측정

결과 측정
실행할 수 있음
Effect of karyotypic abnormalities

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Oncology Group

협력자

National Cancer Institute (NCI)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2003년 12월 1일

기본 완료 (실제)

2006년 9월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2003년 10월 3일

QC 기준을 충족하는 최초 제출

2003년 10월 6일

처음 게시됨 (추정)

2003년 10월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 2월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 2월 19일

마지막으로 확인됨

2014년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .