- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00176839
Stem Cell Transplantation for Hematological Malignancies
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
연구 개요
상태
정황
상세 설명
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents.
Prior to transplantation, they will receive BUSULFAN via the central venous line, four times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's cancer. As well, these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation.
On the day of transplantation, umbilical cord blood from the donor will be transfused via venous line. These new cells will replace the subject's bone marrow.
After transplantation, the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will be discharged from the hospital when medically ready. They will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center, University of Minnesota
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.
- Patients must be either:
- - <18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),
- - 19-35 years of age and at least 18 months after initial HCT, or
- - <35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- - Cardiac: ejection fraction > or = 45%
- - Renal: creatinine clearance > or = 40 mL/min
- - Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- - Karnofsky performance status > or = 70% or Lansky score > or = 50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
- Written informed consent.
Exclusion Criteria:
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
공부 계획
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 Arm
Patients treated with therapy plan consisting of Busulfan every 6 hours on days -7 through -4, Cyclophosphamide 60 mg/kg/day IV x 2 days, Melphalan 140 mg/m on day -1, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation on day 0.
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Certain cancers can be treated by giving patients stem cells that come from someone else.
This is called a stem-cell transplant.
As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer.
As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow.
The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
다른 이름들:
Prior to transplantation, subjects will receive BUSULFAN via the central venous line, four times a day for four days (days -7 through -4).
다른 이름들:
Prior to stem cell transplantation, subjects will receive CYCLOPHOSPHAMIDE via the central venous line once a day for two days on days -3 and -2.
다른 이름들:
MELPHALAN will be given via the central venous line for one day, on day -1, prior to stem cell transplantation.
다른 이름들:
G-CSF is to be given daily IV beginning on day +1 until ANC 2.5 x 109/L.
다른 이름들:
ATG will be administered to umbilical cord blood recipients.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Probability of Long-term Disease-free Survival (DFS)
기간: 1 year
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Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Probability of Engraftment
기간: 1 year
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Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..
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1 year
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Incidence of Acute Graft-versus-host Disease (GVHD)
기간: 100 days post-transplant
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Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
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100 days post-transplant
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Incidence Chronic Graft-versus-host Disease (GVHD)
기간: 1 year
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Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
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1 year
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Incidence of Regimen-related Toxicity 100 Days Post Transplant
기간: 100 days post-transplant
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Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
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100 days post-transplant
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Incidence of Relapse
기간: 1 year
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Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Margaret MacMillan, MD, Masonic Cancer Center, University of Minnesota
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000LS040
- MT2000-12 (기타 식별자: Blood and Marrow Transplantation Program)
- 0005M52481 (기타 식별자: Institutional Review Board, University of Minnesota)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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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