- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01700751
Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation
A Pilot Study of Brentuximab Vedotin in the Prevention of Graft-Versus-Host Disease (GVHD) After Unrelated Allogeneic Stem Cell Transplantation
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patient must be scheduled to undergo stem cell transplantation for one of the following diagnoses:
- acute myeloid leukemia (AML) in CR1 (first complete remission, CR or CRi) or CR2 (second complete remission, CR or CRi),
- acute lymphoblastic leukemia (ALL) in CR1 or CR2 (CR or CRi)
- myelodysplastic syndrome (MDS) without progression to AML.
- Chronic myelogenous leukemia (CML)
- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD)
- Chronic lymphocytic leukemia (CLL)
- Multiple myeloma (MM)
- Patients must be the recipient of unrelated donor peripheral blood stem cell products. Mismatches at both antigen and allele level will be eligible. Match must be 6 or 7 out of 8 loci (HLA A, B, C, and DRB1).
- Patient must receive any one of the following conditioning regimens: total body radiation (single or fractionated dose)/cyclophosphamide, busulfan/ cyclophosphamide, or fludarabine/busulfan/lymphocyte immune globulin (ATGAM/thymo).
- Patient must be ≥ 18 years and ≤ 70 years of age.
- Patient must have an ECOG performance status ≤ 2 or Karnofsky performance scale ≥ 60%
- Patient must have CD34+ stem cells ≥ 2x106/kg (actual body weight of the recipient) available for transplantation.
Patient must have appropriate organ function as defined below (this criterion should be met on screening and on the day of the first dose of brentuximab vedotin (as assessed prior to dosing)):
- Total bilirubin ≤ 2.0 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Serum creatinine ≤ 2.0 x IULN
- Estimated Creatinine Clearance > 30 ml/min
- Cardiac ejection fraction > 40%
- DLCO/VA > 40%
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient must be able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria:
- Patient must not have had prior exposure to brentuximab vedotin.
- Patient must not have a history of other malignancy that has not been in remission for at least 3 years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treated.
- Patient must not be receiving any other investigational agents.
- Patient must not have active CNS involvement.
- Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to brentuximab vedotin or other agents used in the study.
- Patients must not have had previous radiation therapy to the mediastinum or lungs.
- Patient must not have an uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active pulmonary diseases, or psychiatric illness/social situations that would limit compliance with study requirements (this criterion should be met on screening and on the day of but prior to first dose of brentuximab vedotin).
- Patient must not be pregnant and/or breastfeeding.
- Patient must not be known to be HIV-positive on combination antiretroviral therapies.
- Patient must not have had a previous allogeneic or syngeneic transplant. Prior autologous transplant is allowed.
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: Dose Level 0 (starting dose)
brentuximab vedotin 0.3mg/kg, given IV on Days 7, 28, 49 & 70
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다른 이름들:
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실험적: Dose Level 1
brentuximab vedotin 0.6mg/kg, given IV on Days 7, 28, 49 & 70
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다른 이름들:
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실험적: Dose Level 2
brentuximab vedotin 1.2mg/kg, given IV on Days 7, 28, 49 & 70
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다른 이름들:
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실험적: Dose Level 3
brentuximab vedotin 1.8mg/kg, given IV on Days 7, 28, 49 & 70
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다른 이름들:
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간섭 없음: Control Dose Level
The first 3 patients will not receive brentuximab vedotin.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MTD of brentuximab vedotin when administered with a GVHD prophylaxis regimen
기간: 37 days
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Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity; Hematologic DLT is defined as ANC < 500/mm3 for three consecutive days beyond Day +21 that was determined by the investigator to be likely related to brentuximab vedotin. Non-hematologic DLT is defined as any grade 3 or higher non-hematologic toxicity that was determined by the investigator to be possibly, probably, or definitely related to brentuximab vedotin, with the following specific exceptions:
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37 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety and tolerability of brentuximab vedotin when administered with a GVHD prophylaxis regimen
기간: 100 days
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Toxicities described and graded using CTCAE version 4.0; described by patient, type, and grade for each dose level; summarized by counts and percentage of patients in the corresponding categories
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100 days
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Rate of acute GVHD
기간: 100 days
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Proportion of all subjects who experience symptoms consistent with grade 2-4 acute GVHD; using the standard grading system adapted from the Glucksberg clinical stage and grade of acute GVHD
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100 days
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Rate of chronic GVHD
기간: 2 years
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Proportion of all subjects who experience symptoms consistent with chronic GVHD; assessment will begin after Day 100 using the NIH consensus criteria for diagnosis and staging of chronic GVHD
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2 years
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Progression-free survival
기간: 2 years
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Duration from the time of transplant to time of first progression, death, relapse after complete response, or the date the patient was last known to be in remission; estimated with Kaplan-Meier methods.
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2 years
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Overall survival.
기간: 2 years
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Duration from the time of transplant to death or last follow-up; estimated with Kaplan-Meier methods.
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2 years
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1-year non-relapse mortality rate
기간: 1 year
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Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.
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1 year
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2-year non-relapse mortality rate
기간: 2 years
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Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.
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2 years
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1-year disease relapse rate
기간: 1 year
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Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.
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1 year
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2-year disease relapse rate
기간: 2 years
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Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.
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2 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
- 201211047
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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