- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00379587
Rituximab for Prevention of Chronic GVHD
A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation
연구 개요
상세 설명
Study Design: The study is designed as a Phase II, open label trial of Rituximab as chronic GVHD prophylaxis after HLA-matched, related or unrelated peripheral blood stem cell transplantation after ablative or non-ablative conditioning.
Primary Objective: To determine the incidence of clinically extensive chronic GVHD at one and two years after allogeneic stem cell transplantation after a single dose of Rituximab administered at 100 days, 6 months, 9 months and 1 year from transplantation as chronic GVHD prophylaxis.
Secondary Objectives: To determine the incidence of adverse hematological events, the incidence of infectious complications, the rate of malignant relapse, and the effects on donor hematopoietic chimerism after Rituximab administration.
Eligibility Criteria: Eligible patients will be 18 years of age or greater and will have undergone a non-myeloablative or fully ablative transplantation from an HLA-matched (6/6 loci) or single antigen/allele mismatched (5/6) donor approximately 100 days ago. Adequate performance status and organ function will be confirmed prior to enrollment. No ongoing infection or acute GVHD will be present at the time of enrollment. Evidence of sustained donor chimerism will be confirmed prior to study entry.
Treatment Description: Chronic GVHD prophylaxis will consist of Rituximab 375 mg/m2 administered 100 days, 6, 9 and 12 months after transplantation.
Accrual Objective: 68 patients will be accrued over 12 months.
Study Duration: Patients will be evaluated for two years after the time of transplantation for evaluation of the primary and secondary endpoints. Subjects will be followed longitudinally after completion of the study period for determination of clinical status.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation
- Peripheral blood stem cells must have been used as the stem cell source
- Patients must have received transplantation from donors who are identical at 6 HLA loci, or mismatched at no more than 1 locus.
- Patients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment
- 18 years of age or older
- Performance Status 0-2
- Life expectancy of > 100 days
- Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the bone marrow at the time of study entry
Exclusion Criteria:
- Evidence of relapsed or residual malignancy within 30 days of trial entry
- Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like lymphoma
- Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
- Evidence of any active uncontrolled infection, or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV
- Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD
- GVHD with chronic features diagnosed prior to day +100 or prior to enrollment
- Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD
- No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the upcoming 30 days
- Heart failure uncontrolled by medications
- Pregnancy or lactation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years
기간: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
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by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of Grade 3 or Higher Infectious Complications
기간: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
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by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
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Incidence of Relapse or Progression of Disease
기간: by 4 years after peripheral blood stem cell (PBSC) infusion
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Percentage of participants with relapsed disease by year 4 post transplant.
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by 4 years after peripheral blood stem cell (PBSC) infusion
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Incidence of Adverse Hematological Events
기간: by 18 months after peripheral blood stem (PBSC) infusion
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White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.
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by 18 months after peripheral blood stem (PBSC) infusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Corey Cutler, Dana-Farber Cancer Institute
간행물 및 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 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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