In Vitro Drug Sensitivity Testing of Fresh Human Samples

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders

Conditions
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Myeloproliferative Disorders, Lymphoproliferative Disorders

Intervention / Treatment
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* Biological: Blood collection for the evaluation of the anti-drugs sensitivity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age < 18 y.o Pregnant or breastfeeding woman Patients deprived of their liberty by judicial or administrative decision.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphoproliferative disorders<br>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) . | Biological: Blood collection for the evaluation of the anti-drugs sensitivity<br>* The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.<br>|
| Sham Comparator: Control group<br>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) | Biological: Blood collection for the evaluation of the anti-drugs sensitivity<br>* The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.<br>|
| Experimental: Myeloproliferative disorders<br>Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). | Biological: Blood collection for the evaluation of the anti-drugs sensitivity<br>* The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the sensitivity of 10 anti-cancer drugs | Sensitivity determined by in-vitro Tumor cells mortality by Flow cytometry Monitoring of the blasts in the mouse's blood after injection | Through study completion, an average of 3 years | 
| Evaluation of the sensitivity of 10 anti-cancer drugs | Sensitivity determined by in-vivo fresh samples: | Through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematological malignancies, lymphoid, myeloid, multiple myeloma, anticancer drugs, sensitivity, new treatments