- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00268229
Imatinib Mesylate, Daunorubicin, and Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase I Trial of Imatinib Mesylate (Gleevec, Formerly Known as STI571) in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin and cytarabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) and recommended phase II dose of imatinib mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with relapsed acute myeloid leukemia.
Secondary
- Assess the non-dose-limiting toxicities associated with this regimen in these patients.
- Determine any preliminary evidence of clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of imatinib mesylate.
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing until disease progression or unacceptable toxicity. Patients with persistent leukemia on day 14 bone marrow biopsy but ≥ 50% reduction in bone marrow blasts receive 5 more days of cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Ohio
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Bone marrow biopsy confirming acute myeloid leukemia (AML)
- No M3 AML
Patient must have relapsed to standard chemotherapy
- Patients who relapse within six months of response to treatment or those who never responded to an anthracycline/cytarabine combination will be excluded
- At least 20% of peripheral blood or bone marrow blasts positive for c-kit
- No evidence of leptomeningeal involvement
PATIENT CHARACTERISTICS:
- ECOG Performance Status 0-2
- Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal
- Serum creatinine ≤ 2 times upper limit of normal
No New York Heart Association grade III or IV cardiac problems
- Defined as congestive heart failure or myocardial infraction within the past 6 months
- No known chronic liver disease (i.e., chronic active hepatitis and cirrhosis)
- No serious or poorly controlled medical conditions that could be exacerbated by the treatment or would seriously complicate compliance with this study
- No other active primary malignancy unless it is not currently clinically significant and does not require active intervention
- No history of HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No significant history of noncompliance to medical regimens or inability to grant reliable informed consent
PRIOR CONCURRENT THERAPY:
- Previous treatment-related toxicities should be resolved
- No other investigational agents within the past 28 days
No chemotherapy within the past 4 weeks
- 6 weeks for nitrosourea or mitomycin C
- No major surgery within the past 4 weeks
- No concurrent use of the following drugs is allowed: ketoconazole, dilantin, itraconazole, erythromycin, clarithromycin, dexamethasone, rifampin, tegretol, phenobarbital, Hypericum perforatum (St. John's wort), cyclosporine, pimozide, warfarin, certain HMG-CoA reductase inhibitors, traizolo-benzodiazepines, or dihydropyridine calcium channel blockers
- No other concurrent anticancer agents, including chemotherapy and biologic agents
- No other concurrent investigational drugs
- Concurrent medications known to be metabolized by cytochrome p450 enzymes are allowed
No therapeutic anticoagulation with warfarin will be permitted in patients participating in this study
- Therapeutic anticoagulation may be accomplished using low-molecular weight heparin
- Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
- No concurrent routine use of systemic corticosteroid therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Maximum tolerated dose of imatinib mesylate at one year
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Non-dose limiting toxicities associated with imatinib mesylate at one year
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
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
키워드
- 11q23(MLL) 이상이 있는 성인 급성 골수성 백혈병
- inv(16)(p13;q22)가 있는 성인 급성 골수성 백혈병
- t(16;16)(p13;q22)가 있는 성인 급성 골수성 백혈병
- t(8;21)(q22;q22)가 있는 성인 급성 골수성 백혈병
- 재발성 성인 급성 골수성 백혈병
- 성인 급성 거핵모구성 백혈병(M7)
- 성인 급성 최소 분화 골수성 백혈병(M0)
- 성인 급성 단구성 백혈병(M5a)
- 성인 급성 단핵구 백혈병(M5b)
- 성숙한 성인 급성 골수성 백혈병(M2)
- 성숙하지 않은 성인 급성 골수성 백혈병(M1)
- 성인 급성 골수단구성 백혈병(M4)
- 성인 적백혈병(M6a)
- 성인 순수 적혈구성 백혈병(M6b)
추가 관련 MeSH 약관
기타 연구 ID 번호
- CASE-CCF-6441
- P30CA043703 (미국 NIH 보조금/계약)
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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