Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Evaluation of the sensitivity of 10 anti-cancer drugs
研究概览
简要总结
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .
Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.
The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Index cases: patients with myeloproliferative or lymphoproliferative disorders.
- •Controls: patients without hematological disease, without chemotherapy ((≤ 5 years.) and without immunosuppressive treatment at the study time.
- •Age ≥ 18 y.o for all the patients
排除标准
- •Age < 18 y.o
- •Pregnant or breastfeeding woman
- •Patients deprived of their liberty by judicial or administrative decision.
研究组 & 干预措施
Lymphoproliferative disorders
Patients followed in the haematology unit of Hospices Civils de Lyon for lymproliferative disorders as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) .
干预措施: Blood collection for the evaluation of the anti-drugs sensitivity (Biological)
Control group
Patients followed in the medicine of aging unit in the Hospices Civils de Lyon without haematological malignancies, without chemotherapy and without immunosuppressive treatment (≤ 5 years)
干预措施: Blood collection for the evaluation of the anti-drugs sensitivity (Biological)
Myeloproliferative disorders
Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML).
干预措施: Blood collection for the evaluation of the anti-drugs sensitivity (Biological)
结局指标
主要结局
Evaluation of the sensitivity of 10 anti-cancer drugs
时间窗: Through study completion, an average of 3 years
Sensitivity determined by in-vitro * Tumor cells mortality by Flow cytometry * Monitoring of the blasts in the mouse's blood after injection
次要结局
未报告次要终点