NCT05237245招募中不适用
Caractérisation Clinico- Biologique et Survie Des Patients Porteurs d'Une lymphoprolifération HTLV-1 Induite (ou Lymphome/leucémie lié au Virus HTLV-1) et Des Patients infectés Par le Virus HTLV-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of survivors
研究概览
简要总结
The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •HTLV-1 infected
- •T lymphoproliferation induced by HTLV-1 (cohort 1)
- •without T lymphoproliferation induced by HTLV-1 (cohort 2)
- •informed and accepted the collection of data
- •Exclusion Criteria
- •- Patients refusal of participation
排除标准
- 未提供
结局指标
主要结局
Number of survivors
时间窗: Up to 1 year
for cohorts 1 and 2
次要结局
- Number of survivors at 5 years(5 years)
- number of patients with HTLV-1-related extra-hematological disorders(day 1)
- lymphocyte phenotyping of tumor cells(day 1)
- viral integration profile(day 1)
- types of ATL(day 1)
- Number of survivors at 2 years(At 2 years)
- number of patients with HTLV-1-related hematological disorders(day 1)
- chemotherapy-related mortality(during 5 years)
- transplant-related mortality(during 5 years)
- number of progression to ATL(at 2 years)
- HTLV-1 proviral load(day 1)
- Progression free survival (PFS)(during 5 years)
- Number of patients with corticotherapy for extrahematological complications(during 5 years)
- Number of Serious adverse events according to WHO classification related to treatment received(during 5 years)
- genetic analysis of tumor cells by Next-generation sequencing (NGS)(day 1)
- Treatment lines(during 5 years)
- Allograft-specific characteristic(during 5 years)
- Number of progression to ATL(At 5 years)
- Response to induction therapy(during 5 years)
- relapse-related mortality(during 5 years)
- Number of serious adverse events according to WHO classification related to treatment received(during 5 years)
- number of patients with HTLV-1-related extrahematological disorders(during 5 years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Phase II Study of the Efficacy and Toxicity of Ontak(Registered Trademark) (Denileukin Diftitox) in the Therapy of Adult T-Cell LeukemiaLeukemia, Adult T-CellNCT00117845National Cancer Institute (NCI)17
Unknown
不适用
Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy -Pathological ParametersLymphoblastic LymphomaNCT00882011Fondazione Italiana Linfomi - ETS100
已完成
不适用
CAR-T Cell Therapy in Patients With Hematological MalignanciesCART TherapyNCT05390671Grupo Espanol de trasplantes hematopoyeticos y terapia celular260
招募中
1 期
A study to assess the safety and tolerability of next-generation neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) therapy. NEXTGEN-TIL-ACT2024-517021-12-00Vall D Hebron Institute Of Oncology10
招募中
2 期
Clinical Trial of Autologous Tcm Immunotherapy in ICCCholangiocarcinomaNCT03820310Newish Technology (Beijing) Co., Ltd.20