- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00245128
Imatinib Mesylate in Treating Patients With Myelofibrosis
A Phase II Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
- Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.
Secondary
- Determine reduction in marrow fibrosis in patients treated with this drug.
- Determine decrease in spleen size in patients treated with this drug.
OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.
Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Oregon
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Portland, Oregon, 미국, 97239-3098
- OHSU Knight Cancer Institute
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of myelofibrosis with myeloid metaplasia (MMM), defined by all of the following:
- Leukoerythroblastic blood picture
- Fibrosis involving > 1/3 sectional area of bone marrow biopsy
- Splenomegaly (unless patient has undergone prior splenectomy)
- Philadelphia chromosome negative
- No myelodysplastic syndrome
- No systemic disorders associated with marrow fibrosis
Red blood cell transfusion dependent, defined by 1 of the following:
- Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8 weeks
- Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks
- No evidence of disease transformation to acute myelogenous leukemia, defined as > 20% blasts in bone marrow and/or peripheral blood
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver)
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No New York Heart Association grade III-IV heart disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
- No serious, uncontrolled medical condition
- No patients who are considered potentially unreliable or with a history of noncompliance to medical regimens
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 2 weeks since prior interferon alfa
Chemotherapy
- No concurrent chemotherapy except hydroxyurea to control elevated blood counts
Endocrine therapy
- More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM
Other
- More than 4 weeks since other prior treatment for MMM
- No other concurrent experimental drug therapy for MMM
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
기간: At 3,6, and 12 months of therapy
|
A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period. |
At 3,6, and 12 months of therapy
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Reduction in Marrow Fibrosis and Decrease in Spleen Size
기간: After 6 and 12 months of therapy
|
After 6 and 12 months of therapy
|
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000445435
- OHSU-541 (기타 식별자: OHSU IRB)
- OHSU-HEM-01071-L (기타 식별자: OHSU Knight Cancer Institute)
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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