입양 세포 면역 요법을 통한 거대 세포 바이러스 감염 예방 (INMUNOCELL)
Anti-CMV 파일럿 임상시험: 입양세포면역요법을 이용한 조혈전구세포의 일배체 이식에서 거대세포바이러스 감염 예방
Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.
If patient and donor are eligible, it will take 1x10^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.
The CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Miriam Sanchez-Escamilla, MD
- 전화번호: +34646393234
- 이메일: msanchez@idival.org
연구 연락처 백업
- 이름: Lucía Lavín Alconero, Phd
- 이메일: eclinicos5@idival.org
연구 장소
-
-
-
Santander, 스페인
- 모병
- Hospital Marques de Valdecilla
-
연락하다:
- enrique ocio
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
-
Any source of stem cells (peripheral blood or bone marrow).
-
CMV-seropositive donors.
-
Negative pregnancy test in women.
-
Signed writen informed consent.
-
DONORS:
- HLA haploidentical and CMV-seropositve donors.
- Donor must be checked and suitable.
- Signed writen informed consent.
- Donor without active infection evidence at leukapheresis.
Exclusion Criteria:
- Patients without haploidentical CMV-seropositive donors.
- Patients who are not suitable for follow up visits.
CMV-CTLs Infusion Criteria:
- Hematopoiesis recovery at least partial (neutrophil counts >0.5x10^9/L in at least 3 consecutive samples post-transplant).
CMV-CTLs NON-Infusion Criteria:
- Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
- ECOG > or = 3.
- Organic toxicities grade > or = 3.
- Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.
- Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.
- Persistent fevers 3 days before infusion.
- Acute Graft Versus Host Disease (GVHD) grade II-IV.
- Relapse or progression after transplant and before infusion day.
- CMV reactivation/infection after transplant and before infusion day.
Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: CMV CTLs
1x10^5 CMV-CTLs/kg |
The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
100-days incidence of CMV infection
기간: From date of CMV-CTLs infusion to 100 days after transplant
|
Viral load >200 copies in 1 sample |
From date of CMV-CTLs infusion to 100 days after transplant
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-year incidence of CMV specific antiviral drug use
기간: From date of CMV-CTLs infusion to 1 year after transplant
|
If viral load >200 copies in 2 samples or >1000 in 1 sample, treatment with valganciclovir will be started. Time from CMV-CTLs infusion until valganciclovir start and days of valganciclovir. |
From date of CMV-CTLs infusion to 1 year after transplant
|
|
1-year incidence of CMV disease
기간: From date of CMV-CTLs infusion to 1 year after transplant
|
CMV disease P.Lungman criteria. CMV as primary cause of death. |
From date of CMV-CTLs infusion to 1 year after transplant
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-year incidence of CMV-CTLs adverse events
기간: From date of CMV-CTLs infusion to 1 year after transplant
|
Infusion reactions, causes of death, secondary graft failures and graft versus host disease (GVHD). |
From date of CMV-CTLs infusion to 1 year after transplant
|
|
CMV-CTLs persistence
기간: From date of CMV-CTLs infusion to 2 months after infusion
|
Expansion of CMV-CTLs detected by flow cytometry. |
From date of CMV-CTLs infusion to 2 months after infusion
|
|
Immune reconstitution post-HAPLO
기간: From date of transplant to day 180 post-transplant
|
CD3, CD4, CD8, B and NK lymphocyte counts in patient peripheral blood post-transplant (day 30, 60, 90 and 180) detected by flow cytometry. |
From date of transplant to day 180 post-transplant
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Galo Peralta Fernandez, MD, Instituto de Investigación Marqués de Valdecilla
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .