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

Primary Purpose

Myeloproliferative Disorders, Lymphoproliferative Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection for the evaluation of the anti-drugs sensitivity
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myeloproliferative Disorders focused on measuring Hematological malignancies, lymphoid, myeloid, multiple myeloma, anticancer drugs, sensitivity, new treatments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Centre Hospitalier Lyon Sud -Service d'Hématologie
  • Centre Hospitalier Lyon Sud -Service de médecine du vieillissement

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

Lymphoproliferative disorders

Control group

Myeloproliferative disorders

Arm 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) .

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)

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

Outcomes

Primary Outcome Measures

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
Evaluation of the sensitivity of 10 anti-cancer drugs
Sensitivity determined by in-vivo fresh samples:

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
March 2, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05001386
Brief Title
In Vitro Drug Sensitivity Testing of Fresh Human Samples
Acronym
ESAAC
Official Title
Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloproliferative Disorders, Lymphoproliferative Disorders
Keywords
Hematological malignancies, lymphoid, myeloid, multiple myeloma, anticancer drugs, sensitivity, new treatments

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lymphoproliferative disorders
Arm Type
Experimental
Arm 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) .
Arm Title
Control group
Arm Type
Sham Comparator
Arm 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)
Arm Title
Myeloproliferative disorders
Arm Type
Experimental
Arm 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).
Intervention Type
Biological
Intervention Name(s)
Blood collection for the evaluation of the anti-drugs sensitivity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the sensitivity of 10 anti-cancer drugs
Description
Sensitivity determined by in-vitro Tumor cells mortality by Flow cytometry Monitoring of the blasts in the mouse's blood after injection
Time Frame
Through study completion, an average of 3 years
Title
Evaluation of the sensitivity of 10 anti-cancer drugs
Description
Sensitivity determined by in-vivo fresh samples:
Time Frame
Through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Pr DUMONTET, PhD, MD
Phone
0478468340
Email
charles.dumontet@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Pr BONNEFOY, MD
Email
marc.bonnefoy@chu-lyon.fr
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud -Service d'Hématologie
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles DUMONTET, MD
Phone
0478468340
Email
charles.dumontet@chu-lyon.fr
Facility Name
Centre Hospitalier Lyon Sud -Service de médecine du vieillissement
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, MD
Phone
0478861580
Email
marc.bonnefoy@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

In Vitro Drug Sensitivity Testing of Fresh Human Samples

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