Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia
Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.
연구 개요
상태
정황
상세 설명
OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.
OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Groningen, 네덜란드, 9713 EZ
- Academisch Ziekenhuis Groningen
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Arizona
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Tucson, Arizona, 미국, 85724
- Arizona Cancer Center
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California
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento, California, 미국, 95816
- Sutter Cancer Center
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San Diego, California, 미국, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, 미국, 92134-3202
- Naval Medical Center - San Diego
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Santa Clara, California, 미국, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Florida
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Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic
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Miami, Florida, 미국, 33136
- Sylvester Cancer Center, University of Miami
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Miami, Florida, 미국, 33176-2197
- Baptist Hospital of Miami
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Orlando, Florida, 미국, 32803
- Walt Disney Memorial Cancer Institute
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West Palm Beach, Florida, 미국, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
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Hawaii
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Honolulu, Hawaii, 미국, 96859-5000
- Tripler Army Medical Center
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, 미국, 60614
- Children's Memorial Hospital, Chicago
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Oak Lawn, Illinois, 미국, 60453
- Christ Hospital
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Peoria, Illinois, 미국, 61602
- Saint Jude Midwest Affiliate
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Kansas
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Wichita, Kansas, 미국, 67214
- Via Christi Regional Medical Center-Saint Francis Campus
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane University School of Medicine
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Maine
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Bangor, Maine, 미국, 04401
- Eastern Maine Medical Center
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Portland, Maine, 미국, 04101
- Maine Children's Cancer Program
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, 미국, 48236
- St. John's Hospital and Medical Center
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Medical Center
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Keesler AFB, Mississippi, 미국, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Columbia, Missouri, 미국, 65212
- University of Missouri-Columbia Hospital and Clinics
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Norris Cotton Cancer Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- University of New Mexico School of Medicine
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New York
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Stony Brook, New York, 미국, 11790-9832
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73126-0307
- Oklahoma Memorial Hospital
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Tulsa, Oklahoma, 미국, 74136
- Natalie Warren Bryant Cancer Center
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Tennessee
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Johnson City, Tennessee, 미국, 37614-0622
- James H. Quillen College of Medicine
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Texas
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Dallas, Texas, 미국, 75230
- Medical City Dallas Hospital
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Dallas, Texas, 미국, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, 미국, 77555-1329
- University of Texas Medical Branch
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Lackland Air Force Base, Texas, 미국, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Temple, Texas, 미국, 76508
- Scott and White Clinic
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Vermont
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Burlington, Vermont, 미국, 05401-3498
- Vermont Cancer Center
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Virginia
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Falls Church, Virginia, 미국, 22046
- Inova Fairfax Hospital
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Roanoke, Virginia, 미국, 24029
- Carilion Roanoke Memorial Hospital
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Washington
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Tacoma, Washington, 미국, 98431-5000
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, 미국, 25304
- West Virginia University Medical School, Charleston Division
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Morgantown, West Virginia, 미국, 26506-9162
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center
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Geneva, 스위스, 1211
- Clinique de Pediatrie
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Alberta
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Calgary, Alberta, 캐나다, T2T 5C7
- Alberta Children's Hospital
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, 캐나다, H3H 1P3
- Montreal Children's Hospital
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Sainte Foy, Quebec, 캐나다, GIV 4G2
- Centre hospitalier de l'Université Laval
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Santurce, 푸에르토 리코, 00912
- San Jorge Childrens Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)
PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Chemotherapy Treatment
See detailed description.
|
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Event-free survival
기간: 7 years
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7 years
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공동 작업자 및 조사자
수사관
- 연구 의자: Naomi J. Winick, MD, Simmons Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 조직학적 유형에 따른 신생물
- 신생물
- 백혈병
- 약물의 생리적 효과
- 약리작용의 분자기전
- 항감염제
- 자율 작용제
- 말초 신경계 작용제
- 항바이러스제
- 핵산 합성 억제제
- 효소 억제제
- 항염증제
- 항류마티스제
- 항대사물질, 항종양
- 항대사물질
- 항종양제
- 면역억제제
- 면역학적 요인
- 튜불린 조절제
- 항유사분열제
- 유사분열 조절제
- 항구토제
- 위장약
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 보호제
- 항종양제, 알킬화제
- 알킬화제
- 골수 파괴 작용제
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 피부과 약제
- 미량 영양소
- 항생제, 항종양제
- 비타민
- 생식 조절제
- 해독제
- 비타민 B 복합체
- 낙태약제, 비스테로이드성
- 낙태 에이전트
- 엽산 길항제
- 덱사메타손
- 사이클로포스파마이드
- 류코보린
- 레볼류코보린
- 시타라빈
- 메토트렉세이트
- 빈크리스틴
- 다우노루비신
- 아스파라기나제
- 메르캅토퓨린
- 티오구아닌
기타 연구 ID 번호
- 9705
- POG-9705 (기타 식별자: Pediatric Oncology Group)
- CDR0000066768 (기타 식별자: Clinical Trials.gov)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .