In Vitro Drug Sensitivity Testing of Fresh Human Samples (ESAAC)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Myeloproliferative Disorders; Lymphoproliferative Disorders

Treatments: Biological: Blood collection for the evaluation of the anti-drugs sensitivity

Study type: Interventional

Funder types: Other

Identifiers

NCT05001386

69HCL21_0622

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 3 patient groups

Lymphoproliferative disorders

Experimental group

Description:

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) .

Treatment:

Biological: Blood collection for the evaluation of the anti-drugs sensitivity

Control group

Sham Comparator group

Description:

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)

Treatment:

Biological: Blood collection for the evaluation of the anti-drugs sensitivity

Myeloproliferative disorders

Experimental group

Description:

Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML).

Treatment:

Biological: Blood collection for the evaluation of the anti-drugs sensitivity