NCT00882011Unknown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 Parameters
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
研究概览
简要总结
The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic Lymphoma (T-LBL).
详细描述
Observational prospective Clinical Trial designed to:
- record all patients treated with a latest generation ALL-like therapy (e.g.: Holzer, LSA2-L2 modified, GIMEMA LAL094), an enhanced therapy (hyper-CVAD or Stanford), autologous or allogeneic transplant or reduced intensity conditioning allotransplant after induction/consolidation and also expected cases treated with high dose sequential therapy or intensified minimal residual disease (MRD) oriented therapy;
- enter classic T-LBL patients (bone marrow infiltrate <25%) treated as long as previous section;
- monitor therapy response/phenotype ratio by the study of phenotype;
- monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
- evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
- monitor the stage of the disease at diagnosis, during the therapy and during the follow-up by means of TAC, so to value if PET (in association with TAC) is an additional and/or outcome predicting element compared to TAC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no previous therapy, except for treatments to face up to clinical presentation of emergency;
- •medical history initially characterized by nodal mass/masses;
- •histological and immunophenotypic diagnosis that documents the diagnosis of T-LBL; in cases of bone marrow involvement and difficulties in obtaining nodal material, diagnosis could be based on bone marrow;
- •availability of biological material for the study of TCR and gene-profile;
- •age ≥ 15 years;
- •all stages;
- •infiltrated bone marrow <25%;
- •normal liver, renal and cardiac functions, except for alterations directly related to lymphoma;
- •estimates of treatment according to one of the last generation schedules;
- •written informed consent.
排除标准
- •patients with previous HCV, HBsAg+ or suffering from HIV;
- •patients with organic pathology not related to lymphoma.
结局指标
主要结局
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
时间窗: 5 years
次要结局
- To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.(5 years)
- To validated the prognostic systems already identified in T-Acute Lymphoblastic Leukemia cases that can be useful to label the high-risk for Lymphoblastic Lymphoma patients.(5 years)
- To monitor histological and immunophenotypical diagnosis and to make a minimal residual disease (MRD) molecular study in order to verify if minimal residual disease (MRD) prognostic value observed in children is confirmed in adult patients.(5 years)
- To make a gene expression analysis on T-Lymphoblastic Lymphoma patients to detect specific genetic profiles useful to give prognostic and therapy response advices.(5 years)
研究者
研究点 (16)
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