In Vitro Drug Sensitivity Testing of Fresh Human Samples

Not Applicable

Not yet recruiting

• Conditions: Lymphoproliferative Disorders; Myeloproliferative Disorders
• Interventions: Biological: Blood collection for the evaluation of the anti-drugs sensitivity

• Registration Number: NCT05001386
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Status Verified: 2022-03
• Study Start: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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Exclusion Criteria

• Age < 18 y.o
• Pregnant or breastfeeding woman
• Patients deprived of their liberty by judicial or administrative decision.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphoproliferative disorders	Blood collection for the evaluation of the anti-drugs sensitivity	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) .
Control group	Blood collection for the evaluation of the anti-drugs sensitivity	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)
Myeloproliferative disorders	Blood collection for the evaluation of the anti-drugs sensitivity	Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML).

Primary Outcome Measures

Name	Time	Method
Evaluation of the sensitivity of 10 anti-cancer drugs	Through study completion, an average of 3 years	Sensitivity determined by in-vivo fresh samples:

Trial Locations

Locations (2)

Centre Hospitalier Lyon Sud -Service d'Hématologie; 🇫🇷 Pierre-Bénite, France

Centre Hospitalier Lyon Sud -Service de médecine du vieillissement; 🇫🇷 Pierre-Bénite, France