Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
2014년 9월 10일 업데이트: Children's Oncology Group
A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
연구 개요
상태
완전한
정황
상세 설명
OBJECTIVES:
- Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and prednisone in combination with vincristine vs vinblastine, in terms of event-free survival, in patients with advanced anaplastic large cell lymphoma.
- Compare overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Correlate biological tumor characteristics and outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine (VBL).
- Induction therapy: All Patients receive doxorubicin IV over 15 minutes on days 1 and 22; vincristine IV on days 1, 8, 15, 22, and 29; oral prednisone 3 times daily on days 1-28; and intrathecal (IT) methotrexate on days 1, 8, and 22 (patients with central nervous system (CNS) disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36).
Patients undergo restaging after Induction such that consolidation therapy is started on day 43. All patients with complete response (CR), complete response unconfirmed (CRu) or partial response (PR) proceed to Consolidation based on CT or MRI scans at the end of induction (week 6). All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study. Follow-up data will be required unless consent is withdrawn.
Standard APO (Arm I): Patients receive course-specific regimens without vinblastine.
- Courses 1-3: Patients receive doxorubicin IV over 15 minutes, vincristine IV, and methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5.
- Courses 4-5: Patients receive doxorubicin, vincristine, prednisone, and mercaptopurine as in courses 1-3.
- Courses 6-15: Patients receive vincristine, prednisone, and mercaptopurine as in courses 1-3 and methotrexate IV on day 1.
Consolidation with vinblastine (Arm II): Patients receive course-specific regimens including vinblastine.
- Courses 1-3: Patients receive doxorubicin, methotrexate IT, prednisone, and mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15.
- Courses 4-5: Patients receive doxorubicin, prednisone, and mercaptopurine as in arm I and vinblastine as in arm II (courses 1-3).
- Courses 6-15: Patients receive prednisone and mercaptopurine as in arm I, vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1.
In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.
연구 유형
중재적
등록 (실제)
129
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - 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, 90027
- Southern California Permanente Medical Group
-
Loma Linda, California, 미국, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Madera, California, 미국, 93638-8762
- Children's Hospital Central California
-
Orange, California, 미국, 92868
- Children's Hospital of Orange County
-
Sacramento, California, 미국, 95816
- Sutter Cancer Center
-
Sacramento, California, 미국, 95825
- Kaiser Permanente Medical Center - Oakland
-
San Diego, California, 미국, 92123-4282
- Rady Children's Hospital - San Diego
-
San Francisco, California, 미국, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
-
Stanford, California, 미국, 94305-5824
- Stanford Cancer Center
-
-
Colorado
-
Aurora, Colorado, 미국, 80045
- Children's Hospital Center for Cancer and Blood Disorders
-
Denver, Colorado, 미국, 80218
- Presbyterian - St. Luke's Medical Center
-
-
Connecticut
-
Farmington, Connecticut, 미국, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
-
-
Delaware
-
Wilmington, Delaware, 미국, 19803
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010-2970
- Children's National Medical Center
-
-
Florida
-
Fort Lauderdale, Florida, 미국, 33316
- Broward General Medical Center Cancer Center
-
Fort Myers, Florida, 미국, 33901
- Lee Cancer Care of Lee Memorial Health System
-
Hollywood, Florida, 미국, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
-
Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic
-
Miami, Florida, 미국, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
Miami, Florida, 미국, 33155
- Miami Children's Hospital
-
Miami, Florida, 미국, 33176
- Baptist-South Miami Regional Cancer Program
-
Orlando, Florida, 미국, 32803-1273
- Florida Hospital Cancer Institute at Florida Hospital Orlando
-
Orlando, Florida, 미국, 32806
- M.D. Anderson Cancer Center at 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
- Winship Cancer Institute of Emory University
-
Augusta, Georgia, 미국, 30912-3730
- MBCCOP - Medical College of Georgia Cancer Center
-
Savannah, Georgia, 미국, 31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, 미국, 96813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise, Idaho, 미국, 83712-6297
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
-
-
Illinois
-
Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, 미국, 60614
- Children's Memorial Hospital - Chicago
-
Oak Lawn, Illinois, 미국, 60453
- Advocate Christ Medical Center
-
Park Ridge, Illinois, 미국, 60068-1174
- Advocate Lutheran General Cancer Care Center
-
Peoria, Illinois, 미국, 61637
- Saint Jude Midwest Affiliate
-
Springfield, Illinois, 미국, 62794-9677
- Simmons Cooper Cancer Institute
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46202-5289
- Indiana University Melvin and Bren Simon Cancer Center
-
Indianapolis, Indiana, 미국, 46260
- St. Vincent Indianapolis Hospital
-
-
Iowa
-
Des Moines, Iowa, 미국, 50309
- Blank Children's Hospital
-
Iowa City, Iowa, 미국, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kentucky
-
Lexington, Kentucky, 미국, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
-
Louisville, Kentucky, 미국, 40232
- Kosair Children's Hospital
-
-
Louisiana
-
Alexandria, Louisiana, 미국, 71315-3198
- Tulane Cancer Center Office of Clinical Research
-
-
Maryland
-
Baltimore, Maryland, 미국, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
Boston, Massachusetts, 미국, 02111
- Floating Hospital for Children at Tufts - New England Medical Center
-
Springfield, Massachusetts, 미국, 01199-0001
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109-0286
- C.S. Mott Children's Hospital at University of Michigan Medical Center
-
Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Flint, Michigan, 미국, 48503
- Hurley Medical Center
-
Grand Rapids, Michigan, 미국, 49503-2560
- Butterworth Hospital at Spectrum Health
-
Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Kalamazoo, Michigan, 미국, 49007-5381
- CCOP - Kalamazoo
-
Lansing, Michigan, 미국, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
-
Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center at University of Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Cancer Clinic
-
-
Missouri
-
Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
-
Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
-
St. Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68114-4113
- Children's Hospital
-
Omaha, Nebraska, 미국, 68198-6805
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89109-2306
- CCOP - Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center Cancer Center
-
Morristown, New Jersey, 미국, 07962
- Overlook Hospital
-
New Brunswick, New Jersey, 미국, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, 미국, 07503
- St. Joseph's Hospital and Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87131-5636
- University of New Mexico Cancer Center
-
-
New York
-
Bronx, New York, 미국, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
-
Brooklyn, New York, 미국, 11201-5493
- Brooklyn Hospital Center
-
Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
-
New Hyde Park, New York, 미국, 11040
- Schneider Children's Hospital
-
New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
-
Rochester, New York, 미국, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
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
- Mission Hospitals - Memorial Campus
-
Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, 미국, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
-
Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
-
Greenville, North Carolina, 미국, 27835-6028
- Leo W. Jenkins Cancer Center at ECU Medical School
-
Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
North Dakota
-
Fargo, North Dakota, 미국, 58122
- CCOP - MeritCare Hospital
-
-
Ohio
-
Akron, Ohio, 미국, 44308-1062
- Akron Children's Hospital
-
Cincinnati, Ohio, 미국, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, 미국, 44106-5000
- Rainbow Babies and Children's Hospital
-
Columbus, Ohio, 미국, 43205-2696
- Nationwide Children's Hospital
-
Dayton, Ohio, 미국, 45404-1815
- Children's Medical Center - Dayton
-
Toledo, Ohio, 미국, 43606
- Toledo Hospital
-
Toledo, Ohio, 미국, 43614
- Medical University of Ohio Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
-
-
Oregon
-
Portland, Oregon, 미국, 97227
- Legacy Emanuel Hospital and Health Center and Children's Hospital
-
Portland, Oregon, 미국, 97239-3098
- Oregon Health and Science University Cancer Institute
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, 미국, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, 미국, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, 미국, 19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, 미국, 15213
- Children's Hospital of Pittsburgh
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
South Carolina
-
Greenville, South Carolina, 미국, 29605
- Greenville Hospital Cancer Center
-
-
South Dakota
-
Sioux Falls, South Dakota, 미국, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37403
- T.C. Thompson Children's Hospital
-
Knoxville, Tennessee, 미국, 37901
- East Tennessee Children's Hospital
-
Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Amarillo, Texas, 미국, 79106
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
-
Austin, Texas, 미국, 78723
- Dell Children's Medical Center of Central Texas
-
Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, 미국, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, 미국, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
-
Houston, Texas, 미국, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
Houston, Texas, 미국, 77030-2399
- Baylor University Medical Center - Houston
-
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
-
-
Utah
-
Salt Lake City, Utah, 미국, 84113-1100
- Primary Children's Medical Center
-
-
Vermont
-
Burlington, Vermont, 미국, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
-
Norfolk, Virginia, 미국, 23507-1971
- Children's Hospital of The King's Daughters
-
Richmond, Virginia, 미국, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
Roanoke, Virginia, 미국, 24014
- Carilion Medical Center for Children at Roanoke Community Hospital
-
-
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, 98405
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
-
West Virginia
-
Charleston, West Virginia, 미국, 25302
- West Virginia University Health Sciences Center - Charleston
-
-
Wisconsin
-
Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Marshfield, Wisconsin, 미국, 54449
- Marshfield Clinic - Marshfield Center
-
Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
-
-
-
-
-
Bern, 스위스, 3010
- Swiss Pediatric Oncology Group Bern
-
Geneva, 스위스, 1205
- Swiss Pediatric Oncology Group Geneva
-
Lausanne, 스위스, 1011
- Swiss Pediatric Oncology Group Lausanne
-
-
-
-
-
Quebec, 캐나다, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
-
-
Alberta
-
Calgary, Alberta, 캐나다, T3B 6A8
- Alberta Children's Hospital
-
Edmonton, Alberta, 캐나다, T6G 1Z2
- University of Alberta 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
-
Kingston, Ontario, 캐나다, K7L 2V7
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
-
London, Ontario, 캐나다, N6A 5W9
- Children's Hospital of Western Ontario
-
Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital of Eastern Ontario
-
Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal, Quebec, 캐나다, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
-
Montreal, Quebec, 캐나다, H3T 1C5
- Hôpital Sainte Justine
-
-
Saskatchewan
-
Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
-
Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre at the University of Saskatchewan
-
-
-
-
-
Santurce, 푸에르토 리코, 00912
- San Jorge Children's Hospital
-
-
-
-
New South Wales
-
Westmead, New South Wales, 호주, 2145
- Westmead Institute for Cancer Research at Westmead Hospital
-
-
Queensland
-
Brisbane, Queensland, 호주, 4029
- Royal Children's Hospital
-
-
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
20년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
DISEASE CHARACTERISTICS:
Newly diagnosed advanced anaplastic large cell lymphoma
- Cluster of differentiation antigen 30 (CD30+)
- Murphy stage III or IV
- No B-cell large cell lymphoma
- No disease limited to the skin (regardless of how wide-spread)
PATIENT CHARACTERISTICS:
Age
- Under 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2.5 times ULN (unless due to lymphoma)
Renal
- Not specified
Cardiovascular
- Shortening fraction (SF) at least 27% by echocardiogram OR
- Ejection fraction (EF) at least 50% by radionuclide angiogram
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior steroids for management of a mediastinal mass allowed
Radiotherapy
- Prior limited-dose radiotherapy for a mediastinal mass allowed
Surgery
- Not specified
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
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Standard APO with Vincristine (Arm I )
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5.
In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3.
In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1.
Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
주어진 IV
주어진 IV
Given by mouth
Given IV and intrathecally
Given by mouth
|
|
실험적: Consolidation with Vinblastine
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15.
In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3).
In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1.
Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
|
주어진 IV
Given by mouth
Given IV and intrathecally
Given by mouth
주어진 IV
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Event-free Survival (EFS)
기간: From first enrollment up to 3 years.
|
Percentage of EFS patients.
This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause.
To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05)
and the lower critical values are based on testing the alternative hypothesis at 0.005 level.
|
From first enrollment up to 3 years.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Jacqueline Kraveka, DO, Medical University of South Carolina
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 11월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2014년 7월 1일
연구 등록 날짜
최초 제출
2003년 5월 6일
QC 기준을 충족하는 최초 제출
2003년 5월 6일
처음 게시됨 (추정)
2003년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 10일
마지막으로 확인됨
2014년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 림프 증식 장애
- 림프계 질환
- 면역증식성 장애
- 림프종, 비호지킨
- 림프종, T 세포
- 림프종
- 림프종, 대세포, 역형성
- 약물의 생리적 효과
- 약리작용의 분자기전
- 핵산 합성 억제제
- 효소 억제제
- 항염증제
- 항류마티스제
- 항대사물질, 항종양
- 항대사물질
- 항종양제
- 면역억제제
- 면역학적 요인
- 튜불린 조절제
- 항유사분열제
- 유사분열 조절제
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 피부과 약제
- 항생제, 항종양제
- 생식 조절제
- 낙태약제, 비스테로이드성
- 낙태 에이전트
- 엽산 길항제
- 프레드니손
- 독소루비신
- 리포솜 독소루비신
- 메토트렉세이트
- 빈크리스틴
- 메르캅토퓨린
- 빈블라스틴
기타 연구 ID 번호
- ANHL0131
- CDR0000298777 (기타 식별자: Clinical Trials.gov)
- COG-ANHL0131 (기타 식별자: Children's Oncology Group)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
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. .