In Vitro Drug Sensitivity Testing of Fresh Human Samples

Myeloproliferative Disorders Clinical Trial

— ESAAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05001386
• Other study ID #: 69HCL21_0622
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: Charles Pr DUMONTET, PhD, MD
• Phone: 0478468340
• Email: charles.dumontet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Hypersensitivity
• Lymphoproliferative Disorders
• Myeloproliferative Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud -Service d'Hématologie	Pierre-Bénite
France	Centre Hospitalier Lyon Sud -Service de médecine du vieillissement	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluation of the sensitivity of 10 anti-cancer drugs	Sensitivity determined by in-vivo fresh samples:	Through study completion, an average of 3 years