In Vitro Drug Sensitivity Testing of Fresh Human Samples

NCT05001386 | Unknown

• 1 other identifier: 69HCL21_0622
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

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.

Conditions

Myeloproliferative Disorders; Lymphoproliferative Disorders

Keywords

Hematological malignancies; lymphoid; myeloid; multiple myeloma; anticancer drugs; sensitivity; new treatments

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Lymphoproliferative disorders

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Myeloproliferative disorders

EXPERIMENTAL

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

Interventions

Blood collection for the evaluation of the anti-drugs sensitivity BIOLOGICAL

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.

Control group; Lymphoproliferative disorders; Myeloproliferative disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Centre Hospitalier Lyon Sud -Service d'Hématologie

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Lyon Sud -Service de médecine du vieillissement

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Lymphoproliferative Disorders; Hematologic Neoplasms; Multiple Myeloma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Neoplasms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Central Study Contacts

Charles Pr DUMONTET, PhD, MD

CONTACT

0478468340; charles.dumontet@chu-lyon.fr

Marc Pr BONNEFOY, MD

CONTACT

marc.bonnefoy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 11, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

FR (2)