- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00993486
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
연구 개요
상태
상세 설명
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
|
실험적: L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
기간: Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Immune reconstitution
기간: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Rate of disease relapse
기간: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence and severity of graft-versus-host disease
기간: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence of adverse drug reactions
기간: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
|
Incidence and severity of infections
기간: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Denis-Claude Roy, MD, Maisonneuve-Rosemont Hospital, Montréal, Canada
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. .