- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00002833
Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
연구 개요
상태
상세 설명
OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable.
OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is gradually tapered.
PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- University of Texas - MD Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Acute leukemia with poor risk cytogenetic features (-5,-7, +8) in first complete remission Poor risk myelodysplasia Refractory anemia with excess blasts (RAEB) RAEB in transformation (RAEB-T) Chronic myelomonocytic leukemia (CMML) Chronic myelogenous leukemia (CML) in late chronic phase Acute leukemia with greater than first complete remission or transformed CML or CMML
PATIENT CHARACTERISTICS: Age: 55 to 65 65 to 70 (at the discretion of study chairperson on basis of performance status) 55 and under (if declined for conventional high dose chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50, FEV1, FVC, or DLCO less than 50%, abnormal LFTs) Performance status: Zubrod less than 2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Serum creatinine less than 2 mg/dL Cardiovascular: Ejection fraction greater than 40% per MUGA scan Pulmonary: Not specified Other: No active uncontrolled infection HLA compatible donor capable of donating stem cells via apheresis
PRIOR CONCURRENT THERAPY: Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Group 1A
Group 1A - With or Without Remission + Failing Fludarabine therapy: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3 with Cladribine continuous infusion for 5 days, beginning 4 hours before Ara-C first dose. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered. |
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
다른 이름들:
Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
다른 이름들:
For GVHD prophylaxis, cyclosporine via continuous IV infusion.
Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion.
Then dose tapered 10% weekly until discontinued.
다른 이름들:
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
다른 이름들:
IV Days -6, -5 and -4.
다른 이름들:
Begins 5 days after infusion and is gradually tapered.
다른 이름들:
Cell infusion Day 0.
다른 이름들:
|
실험적: Group 1B
Group 1B: With or Without Remission, No previous Fludara Therapy Fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered. |
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
다른 이름들:
For GVHD prophylaxis, cyclosporine via continuous IV infusion.
Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion.
Then dose tapered 10% weekly until discontinued.
다른 이름들:
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
다른 이름들:
IV Days -6, -5 and -4.
다른 이름들:
Begins 5 days after infusion and is gradually tapered.
다른 이름들:
Cell infusion Day 0.
다른 이름들:
IV over 30 minutes daily on days -6, -5, -4 and -3.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Toxic Effects of Peripheral Stem Cell Transplantation + Filgrastim
기간: 24 - 36 months
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Effectiveness as determined by toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy
|
24 - 36 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Sergio Giralt, MD, M.D. Anderson Cancer Center
간행물 및 유용한 링크
유용한 링크
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
추가 관련 MeSH 약관
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 신생물
- 골수 질환
- 혈액 질환
- 골수증식성 장애
- 골수이형성 증후군
- 백혈병
- 백혈병, 골수성
- 백혈병, 골수성, 만성, BCR-ABL 양성
- 이식 대 숙주 질병
- 약물의 생리적 효과
- 약리작용의 분자기전
- 항감염제
- 자율 작용제
- 말초 신경계 작용제
- 항바이러스제
- 효소 억제제
- 항염증제
- 항류마티스제
- 항대사물질, 항종양
- 항대사물질
- 항종양제
- 면역억제제
- 면역학적 요인
- 항구토제
- 위장약
- 글루코 코르티코이드
- 호르몬
- 호르몬, 호르몬 대체물 및 호르몬 길항제
- 항종양제, 호르몬
- 신경보호제
- 보호제
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 피부과 약제
- 항생제, 항종양제
- 항진균제
- 칼시뉴린 억제제
- 프레드니솔론
- 메틸프레드니솔론 아세테이트
- 메틸프레드니솔론
- 메틸프레드니솔론 헤미숙시네이트
- 프레드니솔론 아세테이트
- 프레드니솔론 헤미숙시네이트
- 프레드니솔론 인산염
- 플루다라빈
- 플루다라빈 포스페이트
- 시타라빈
- 이다루비신
- 클라드리빈
- 사이클로스포린
- 사이클로스포린
기타 연구 ID 번호
- DM94-078
- P30CA016672 (미국 NIH 보조금/계약)
- MDA-DM-94078 (기타 식별자: UT MD Anderson Cancer Center)
- NCI-G96-1001
- CDR0000065035 (레지스트리 식별자: NCI PDQ)
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. .
Filgrastim에 대한 임상 시험
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Cancer Institute and Hospital, Chinese Academy...Zhejiang Cancer Hospital; Changhai Hospital; Fudan University; Fujian Cancer Hospital; Peking... 그리고 다른 협력자들완전한
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Sidney Kimmel Cancer Center at Thomas Jefferson...완전한
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Xiamen Amoytop Biotech Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical Sciences완전한