- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00049569
Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse
연구 개요
상태
정황
상세 설명
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of using an intensified sequential induction regimen to treat children with acute lymphoblastic leukemia (ALL), who experience an isolated, or combined bone marrow relapse.
II. To determine the potential of this regimen to serve, as a backbone, for the future testing of novel therapeutic agents.
SECONDARY OBJECTIVES:
I. To estimate the remission re-induction rates and four-month event-free survival (EFS) for children, stratified by the duration of first remission.
II. To determine the feasibility of measuring minimal residual disease (MRD) quantitatively in all patients at time points throughout re-induction, and to correlate post-remission events with disease burden during induction.
III. To use deoxyribonucleic acid (DNA) arrays to characterize patterns of gene expression that predict treatment failure, and to compare gene expression profiles at the time of relapse with those at the time of initial diagnosis to gain an understanding of the pathways that may be involved in disease recurrence.
IV. To determine the feasibility of combining intensive re-induction therapy with imatinib mesylate (STI571) for children with a relapse of Philadelphia chromosome positive (Ph+) ALL.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I:
Treatment Block 1: Patients receive cytarabine intrathecally (IT) on day 1 and methotrexate IT on days 15 and 29. Patients also receive vincristine intravenously (IV) on days 1, 8, 15, and 22; prednisone orally (PO) twice or thrice daily (BID or TID) on days 1-29; pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22; and doxorubicin IV over 15 minutes on day 1. Ph-positive patients also receive imatinib mesylate PO on days 1-14.
Treatment Block 2: Patients receive methotrexate IT on days 1 and 22, cyclophosphamide IV over 30 minutes and etoposide IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover. Patients also receive methotrexate IV over 24 hours on day 22 followed by leucovorin calcium IV every 6 hours on days 24 and 25. Ph-positive patients receive imatinib mesylate PO on days 1-14.
Treatment Block 3a (Ph-negative patients): Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, asparaginase IM on days 2 and 9, and G-CSF SC beginning on day 10 and continuing until blood counts recover.
Treatment Block 3b (Ph-positive patients): Patients receive cytarabine IV over 3 hours every 12 hours on days 1 and 2, asparaginase IM on day 2, and G-CSF SC beginning on day 3 and continuing until blood counts recover. Patients also receive imatinib mesylate PO on days 1-14.
ARM II:
Treatment Block 1: Patients receive cytarabine IT on day 1 and then methotrexate, cytarabine and hydrocortisone IT (triple intrathecal therapy; TIT) on days 8, 15, 22, and 29. Vincristine, prednisone, pegaspargase, doxorubicin, and imatinib mesylate are administered as in arm I.
Treatment Block 3: Patients receive cytarabine, asparaginase, G-CSF, and imatinib mesylate as in arm I.
Treatment Block 2: Patients receive TIT on days 1 and 22. Patients then receive cyclophosphamide, etoposide, G-CSF, methotrexate IV, leucovorin calcium, and imatinib mesylate as in arm I. After each block is completed, disease is assessed. The next block is started on day 36 if blood counts have recovered and marrow during block 1 is at least M2/M3. Patients are removed from protocol therapy if disease progresses, unacceptable toxicity occurs, marrow is M2/M3 at day 15 of the second administered block of treatment, or cerebrospinal fluid blasts persist after 6 weekly doses of TIT.
After completion of study treatment, patients are followed up for 4 months.
PROJECTED ACCRUAL: A total of 63-126 patients will be accrued for this study within 14 months.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Arcadia, California, 미국, 91006-3776
- Children's Oncology Group
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
- Shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
- Cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
- Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
- They received SCT less than 12 months prior to study entry
- They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
- They have active fungal infection at time of study entry
- They have had invasive filamentous fungal infection at any time post-SCT
- Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
- Patients with prior isolated extramedullary relapse are ineligible
공부 계획
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: 팔 I
자세한 설명을 참조하십시오.
|
주어진 IV
주어진 IV
주어진 IV
주어진 IV
주어진 IV
주어진 IT
주어진 IM
주어진 IT
주어진 SC
주어진 PO
주어진 IM
주어진 PO
|
실험적: Arm II
See detailed description.
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주어진 IV
주어진 IV
주어진 IV
주어진 IV
주어진 IV
주어진 IT
주어진 IM
주어진 IT
주어진 SC
주어진 PO
주어진 IM
주어진 IT
주어진 PO
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Feasibility assessed by excessive early deaths, induction failures, and early relapses
기간: Up to 4 months
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Up to 4 months
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Toxicity assessed using CTC version 2.0
기간: Up to 4 months
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Will be tabulated in detail.
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Up to 4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall remission reinduction (CR2) rate
기간: Up to 4 months
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Up to 4 months
|
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EFS
기간: 4 months
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The Kaplan-Meier method will be used.
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4 months
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MRD
기간: Up to 4 months
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The percentage of MRD positive patients will be estimated at the end of each block.
Cox regression will be utilized to correlate MRD values with EFS.
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Up to 4 months
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Feasibility of combining intensive re-induction therapy with imatinib mesylate
기간: Up to 4 months
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Will be determined using descriptive statistics due to the small sample size.
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Up to 4 months
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Percentage of patients who were able to complete the triple re-induction therapy with imatinib mesylate
기간: Up to 4 months
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Will be estimated.
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Up to 4 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Elizabeth Raetz, Children's Oncology Group
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 림프 증식 장애
- 림프계 질환
- 면역증식성 장애
- 백혈병
- 전구 세포 림프구성 백혈병-림프종
- 백혈병, 림프
- 약물의 생리적 효과
- 약리작용의 분자기전
- 항감염제
- 항바이러스제
- 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
- 보호제
- 항종양제, 알킬화제
- 알킬화제
- 골수 파괴 작용제
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 피부과 약제
- 미량 영양소
- 단백질 키나제 억제제
- 항생제, 항종양제
- 비타민
- 생식 조절제
- 해독제
- 비타민 B 복합체
- 낙태약제, 비스테로이드성
- 낙태 에이전트
- 엽산 길항제
- 사이클로포스파마이드
- 에토포사이드
- 류코보린
- 레볼류코보린
- 프레드니손
- 독소루비신
- 리포솜 독소루비신
- 시타라빈
- 메토트렉세이트
- 빈크리스틴
- 아스파라기나제
- 이마티닙 메실레이트
- 하이드로코르티손
- 하이드로코르티손 17-부티레이트 21-프로피오네이트
- 히드로코르티손 아세테이트
- 히드로코르티손 헤미숙시네이트
- 페가스파가제
기타 연구 ID 번호
- NCI-2012-01798 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- U10CA098543 (미국 NIH 보조금/계약)
- COG-AALL01P2
- CDR0000258120
- AALL01P2 (기타 식별자: CTEP)
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. .
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