ESAAC: In Vitro Drug Sensitivity Testing of Fresh Human Samples

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05001386

Collaborator

(none)

800

Enrollment

Locations

Arms

Anticipated Duration (Months)

400

Patients Per Site

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloproliferative Disorders Lymphoproliferative Disorders	Biological: Blood collection for the evaluation of the anti-drugs sensitivity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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) .	Biological: Blood collection for the evaluation of the anti-drugs sensitivity 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.
Sham Comparator: 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)	Biological: Blood collection for the evaluation of the anti-drugs sensitivity 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.
Experimental: 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).	Biological: Blood collection for the evaluation of the anti-drugs sensitivity 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.

Arm

Intervention/Treatment

Experimental: 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) .

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

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.

Sham Comparator: 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)

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

Experimental: 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).

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Lyon Sud -Service d'Hématologie	Pierre-Bénite		France	69495
2	Centre Hospitalier Lyon Sud -Service de médecine du vieillissement	Pierre-Bénite		France	69495