- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07662382
Cousin vs. Sibling Donors in Haplo-HSCT
Comparison of Outcomes of Haploidentical Hematopoietic Stem Cell Transplantation From Cousin Donors Versus Sibling Donors in Patients With Hematological Malignancies: A Target Trial Emulation Study
This observational study aims to emulate a hypothetical pragmatic, multicenter, non-blinded clinical trial enrolling adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with grafts derived from either cousin or sibiling donors.
The main research question is whether cousin donor-derived haplo-HSCT is associated with inferior clinical outcomes relative to sibling donor-derived haplo-HSCT.
Study participants consist of adult patients diagnosed with hematological malignancies who underwent cousin or sibiling haplo-HSCT between 2017 and 2024, and all eligible recipients will receive regular follow-up assessments.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Jiangsu
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Suzhou, Jiangsu, 중국, 215000
- The First Affiliated Hospital of Soochow University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients diagnosed with hematological malignancies, including acute leukemia (AL), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL)
- Receipt of first haploidentical hematopoietic stem cell transplantation between 2017 and 2024
- Documented exact date of transplantation available in medical charts
- Verifiable donor kinship classified as either cousin or sibiling
- Complete longitudinal follow-up data accessible for outcome assessment
Exclusion Criteria:
- Prior receipt of any form of hematopoietic stem cell transplantation
- An age difference of more than 18 years between the donor and recipient
- Failure of successful infusion of donor-derived hematopoietic stem cells following conditioning regimen
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Cousin haplo-HSCT
Patients who underwent haploidentical hematopoietic stem cell transplantation with cousin donors.
Grouping was based on donor age recorded in retrospective clinical data.
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Sibling haplo-HSCT
Patients who underwent haploidentical hematopoietic stem cell transplantation with sibling donors.
Grouping was based on donor age recorded in retrospective clinical data.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival
기간: 2 years after transplantation
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estimated overall survival at 2 year
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2 years after transplantation
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Graft-versus-host disease-free and relapse-free survival
기간: 2 years after transplantation
|
estimated graft-versus-host disease-free and relapse-free survival at 2 year
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2 years after transplantation
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Cumulative incidence of acute graft-versus-host disease
기간: 180 days after transplantation
|
estimated cumulative incidence of acute graft-versus-host disease at 180 day
|
180 days after transplantation
|
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Cumulative incidence of chronic graft-versus-host disease
기간: 2 years after transplantation
|
estimated cumulative incidence of chronic graft-versus-host disease at 2 year
|
2 years after transplantation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cumulative incidence of relapse
기간: 2 years after transplantation
|
estimated cumulative incidence of relapse at 2 year
|
2 years after transplantation
|
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Non-relapse mortality
기간: 2 years after transplantation
|
estimated non-relapse mortality at 2 year
|
2 years after transplantation
|
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Cumulative incidence of grade III-IV acute graft-versus-host disease
기간: 180 days after transplantation
|
estimated cumulative incidence of grade III-IV acute graft-versus-host disease at 180 day
|
180 days after transplantation
|
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Cumulative incidence of extensive chronic graft-versus-host disease
기간: 2 years after transplantation
|
estimated cumulative incidence of extensive chronic graft-versus-host disease at 2 year
|
2 years after transplantation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yang Xu, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .