이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

2014년 11월 13일 업데이트: National Cancer Institute (NCI)

A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG

This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

PRIMARY OBJECTIVES:

I. Determine the activity of imatinib mesylate (Gleevec) to prolong disease-free survival (DFS) and overall survival in acute lymphoblastic leukemia (ALL) patients with t(9;22).

II. Determine the ability of imatinib mesylate (Gleevec) to produce or maintain a BCR-ABL-negative status, as judged by real-time-polymerase chain reaction (RT-PCR) following sequential chemotherapy, imatinib mesylate (Gleevec) and transplantation.

III. Determine the feasibility of collecting adequate peripheral blood stem cells for autologous transplantation following imatinib mesylate (Gleevec) therapy.

IV. Study the safety and efficacy of autologous peripheral stem cell transplantation following therapy with imatinib mesylate (Gleevec).

V. Study the safety and efficacy of allogeneic stem cell transplantation following therapy with imatinib mesylate (Gleevec).

VI. Study the safety and efficacy of imatinib mesylate (Gleevec) administered after allogeneic or autologous stem cell transplant.

OUTLINE:

COURSE I (remission induction): Patients receive 1 course of front-line induction therapy on a Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) protocol prior to enrollment.

COURSE II (imatinib mesylate): Patients receive imatinib mesylate orally (PO) twice daily on days 1-28.

COURSE III (CNS prophylaxis): Within 7 days after completing course II, patients receive methotrexate intrathecally (IT), methotrexate intravenously (IV) over 3 hours, and vincristine sulfate IV on days 1, 8, and 15; methotrexate PO every 6 hours on days 1-2, 8-9, and 15-16; leucovorin calcium IV on days 2, 9, and 16; and leucovorin calcium PO every 6 hours on days 3, 4, 10, 11, 17, and 18.

COURSE IV (imatinib mesylate): After blood counts recover after completion of course III, patients receive imatinib mesylate as in course II.

COURSE V: Patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT), autologous PBSCT, or no PBSCT.

COURSE Va (allogeneic PBSCT for patients with human leukocyte antigen [HLA]-matched sibling donor): Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim subcutaneously (SC) beginning on day 4 and continuing until blood counts recover.

COURSE Vb (autologous PBSCT for patients without HLA-matched sibling donor): Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive filgrastim SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive filgrastim SC beginning on day 0 and continuing until blood counts recover.

COURSE Vc (no transplantation for patients who are not transplant candidates): Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive filgrastim SC once or twice a day beginning on day 14 and continuing until blood counts recover.

COURSE VI: Patients receive imatinib mesylate PO once or twice daily beginning on day 30 post transplantation or on day 30 if no transplantation received and continuing for at least 1 year or until patient has 2 consecutive negative reverse transcriptase-polymerase chain reaction assays at least 3 months apart or until relapse.

After completion of study treatment, patients are followed up monthly for 1 year, every 3 months for 2 years, every 6 months for 2 years, then yearly for 5 years.

연구 유형

중재적

등록 (실제)

58

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • Blood and Marrow Transplant Group of Georgia
    • Illinois
      • Bloomington, Illinois, 미국, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, 미국, 61520
        • Graham Hospital Association
      • Carthage, Illinois, 미국, 62321
        • Memorial Hospital
      • Chicago, Illinois, 미국, 60637
        • University of Chicago
      • Chicago, Illinois, 미국, 60640
        • Weiss Memorial Hospital
      • Eureka, Illinois, 미국, 61530
        • Eureka Hospital
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, 미국, 61401
        • Illinois CancerCare Galesburg
      • Havana, Illinois, 미국, 62644
        • Mason District Hospital
      • Hopedale, Illinois, 미국, 61747
        • Hopedale Medical Complex - Hospital
      • Macomb, Illinois, 미국, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, 미국, 60153
        • Loyola University Medical Center
      • Normal, Illinois, 미국, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, 미국, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, 미국, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, 미국, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, 미국, 61554
        • Pekin Cancer Treatment Center
      • Pekin, Illinois, 미국, 61554
        • Pekin Hospital
      • Peoria, Illinois, 미국, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, 미국, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, 미국, 61614
        • Proctor Hospital
      • Peoria, Illinois, 미국, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, 미국, 61615
        • Illinois Oncology Research Association CCOP
      • Peru, Illinois, 미국, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, 미국, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, 미국, 61362
        • Saint Margaret's Hospital
    • Indiana
      • Fort Wayne, Indiana, 미국, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
    • Kansas
      • Chanute, Kansas, 미국, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, 미국, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, 미국, 67042
        • Cancer Center of Kansas - El Dorado
      • Kansas City, Kansas, 미국, 66112
        • Providence Medical Center
      • Kingman, Kansas, 미국, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, 미국, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, 미국, 67114
        • Cancer Center of Kansas - Newton
      • Olathe, Kansas, 미국, 66061
        • Radiation Oncology Center of Olathe
      • Overland Park, Kansas, 미국, 66210
        • Radiation Oncology Practice Corporation Southwest
      • Parsons, Kansas, 미국, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, 미국, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, 미국, 67401
        • Salina Regional Health Center
      • Salina, Kansas, 미국, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, 미국, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, 미국, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, 미국, 67208
        • Associates In Womens Health
      • Wichita, Kansas, 미국, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, 미국, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, 미국, 67214
        • Wichita CCOP
      • Winfield, Kansas, 미국, 67156
        • Cancer Center of Kansas - Winfield
    • Maine
      • Bangor, Maine, 미국, 04401
        • Eastern Maine Medical Center
    • Massachusetts
      • Beverly, Massachusetts, 미국, 01915
        • Beverly Hospital
      • Gloucester, Massachusetts, 미국, 01930
        • Addison Gilbert Hospital
      • Worcester, Massachusetts, 미국, 01605
        • Commonwealth Hematology Oncology PC-Worcester
    • Missouri
      • Independence, Missouri, 미국, 64057
        • Centerpoint Medical Center LLC
      • Kansas City, Missouri, 미국, 64111
        • Saint Luke's Cancer Institute
      • Kansas City, Missouri, 미국, 64114
        • Radiation Oncology Practice Corporation South
      • Kansas City, Missouri, 미국, 64154
        • Radiation Oncology Practice Corporation - North
      • Liberty, Missouri, 미국, 64068
        • Liberty Hospital
      • Saint Louis, Missouri, 미국, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, 미국, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, 미국, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, 미국, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, 미국, 59102
        • Hematology-Oncology Centers of the Northern Rockies PC
      • Billings, Montana, 미국, 59107-7000
        • Billings Clinic
      • Billings, Montana, 미국, 59107
        • Deaconess Medical Center
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconess Cancer Center
      • Bozeman, Montana, 미국, 59715
        • Internal Medicine of Bozeman
      • Butte, Montana, 미국, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic
      • Great Falls, Montana, 미국, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Helena, Montana, 미국, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, 미국, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, 미국, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, 미국, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, 미국, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, 미국, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, 미국, 59801
        • Community Medical Hospital
      • Missoula, Montana, 미국, 59802
        • Montana Cancer Specialists
    • New Hampshire
      • Keene, New Hampshire, 미국, 03431
        • Cheshire Medical Center-Dartmouth-Hitchcock Keene
      • Rochester, New Hampshire, 미국, 03867
        • Frisbie Hospital
    • New York
      • Buffalo, New York, 미국, 14263
        • Roswell Park Cancer Institute
      • Manhasset, New York, 미국, 11030
        • North Shore University Hospital
      • Manhasset, New York, 미국, 11030
        • North Shore-LIJ Health System CCOP
      • New Hyde Park, New York, 미국, 11040
        • Long Island Jewish Medical Center
      • New Hyde Park, New York, 미국, 11040
        • North Shore-LIJ Health System/Center for Advanced Medicine
      • New York, New York, 미국, 10065
        • Weill Medical College of Cornell University
      • Oswego, New York, 미국, 13126
        • Oswego Hospital
      • Rochester, New York, 미국, 14642
        • University of Rochester
      • Syracuse, New York, 미국, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Kinston, North Carolina, 미국, 28501
        • Kinston Medical Specialists PA
      • Winston-Salem, North Carolina, 미국, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15224-1791
        • Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina
    • Vermont
      • St. Johnsbury, Vermont, 미국, 05819
        • Northeastern
    • Virginia
      • Richmond, Virginia, 미국, 23298
        • Virginia Commonwealth University
    • Wyoming
      • Sheridan, Wyoming, 미국, 82801
        • Welch Cancer Center

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

15년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Unequivocal histologic diagnosis of ALL
  • Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive by molecular analysis (RT-PCR or fluorescence in situ hybridization [FISH})

  • Prior Therapy:

    • Complete or partial remission following one course of induction chemotherapy with an intensive 4 or 5 drug regimen (with or without imatinib mesylate) on a CALGB or SWOG ALL protocol for previously untreated ALL patients

      • Note: The double induction regimen of SWOG S0333 is considered to be one course of induction chemotherapy for the purpose of this eligibility criterion; therefore, patients from S0333 may be eligible for this study only after completing the entire double induction regimen

    • Complete or partial remission following one course of therapy on any standard induction regimen (with or without imatinib mesylate) without prior enrollment on a cooperative group frontline protocol; in these instances, documentation of Philadelphia chromosome (Ph)+ positivity may occur outside a CALGB or SWOG laboratory

      • Note: CALGB institutions must enroll patients on CALGB 9862 and submission of an initial sample for the companion trial must occur at time of enrollment on CALGB C10001; enrollment on companion studies CALGB 8461 and 9665 is not required
  • No more than six weeks of prior imatinib mesylate during induction therapy before study enrollment
  • Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control and contraception should continue for three months after the last dose of imatinib mesylate (Gleevec) to allow complete clearance of drug and its principle metabolites from the body; in women of childbearing potential, a pregnancy test will be required at study entry

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment (imatinib mesylate, chemotherapy, PBSCT)
See Detailed Description.
다른: 실험실 바이오마커 분석
상관 연구
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • 엔독산
  • CPM
  • CTX
  • 엔독사나
의약품: 에토포사이드
주어진 IV
다른 이름들:
  • 에펙
  • VP-16
  • VP-16-213
의약품: 시타라빈
주어진 IV
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • 아라-C
  • 아라비노푸라노실시토신
  • 아라비노실시토신
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 류로크리스틴 황산염
  • 빈카사르 PFS
생물학적: 필그라스팀
주어진 SC
다른 이름들:
  • G-CSF
  • 뉴포겐
방사능: 전신 조사
TBI를 받다
다른 이름들:
  • TBI
의약품: 타크로리무스
주어진 IV 또는 PO
다른 이름들:
  • 프로그라프
  • FK 506
절차: 동종 조혈모세포이식
동종이계 PBSCT 진행
절차: 말초혈액 줄기세포 이식
PBSCT 받기
다른 이름들:
  • PBPC 이식
  • PBSC 이식
  • 말초 혈액 전구 세포 이식
  • 이식, 말초혈액줄기세포
절차: 자가조혈모세포이식
자가 PBSCT 받기
의약품: 이마티닙 메실레이트
주어진 PO
다른 이름들:
  • 글리벡
  • CGP 57148
의약품: 류코보린칼슘
주어진 IV와 PO
다른 이름들:
  • CF
  • CFR
  • LV
의약품: methotrexate
Given IT and IV
다른 이름들:
  • 아메토프테린
  • 폴렉스
  • 메틸아미노프테린
  • 멕세이트
  • MTX

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Disease Free Survival
기간: Duration of treatment (up to 10 years)

Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.

A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month.
Duration of treatment (up to 10 years)

2차 결과 측정

결과 측정
측정값 설명
기간
전반적인 생존
기간: 학습 기간(최대 10년)
연구 날짜부터 사망까지의 간격으로서의 전체 생존(OS). OS는 Kaplan Meier 방법을 사용하여 추정되었습니다.
학습 기간(최대 10년)
Number of Participants Who Achieved a BCR-ABL Response at 12 Months
기간: 12 months

BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).

Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene

MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).
12 months
5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups
기간: 5 years from CR
Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
5 years from CR
5 Year Overall Survival for Autologous & Allogeneic Transplant Groups
기간: 5 years from registration
Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.
5 years from registration

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Meir Wetzler, Cancer and Leukemia Group B

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

2002년 4월 1일

기본 완료 (실제)

2012년 4월 1일

연구 완료 (실제)

2014년 2월 1일

연구 등록 날짜

최초 제출

2002년 6월 6일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 11월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 11월 13일

마지막으로 확인됨

2014년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2009-00436 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • U10CA031946 (미국 NIH 보조금/계약)
  • CDR0000069378
  • CALGB 10001/SWOG C10001 (기타 식별자: Cancer and Leukemia Group B)
  • CALGB-10001 (기타 식별자: CTEP)

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