Single Cell Acute Leukemia Analysis

NCT06906978 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_00392025-A00734-45.
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Numerous chemotherapy and immunotherapy resistance genes have been identified in cancers in general and acute myeloid leukemia in particular. As a preliminary to this study, the investigators hypothesized the co-expression of these genes in the same cell as a major factor in relapse. This hypothesis was supported in vitro by the study of the evolution of these co-expressions after incubation with chemotherapy drugs. The current study aims to verify this hypothesis by studying the expression of these genes in single-cell samples from relapsed acute myeloid leukemia patients.

Conditions

Acute Myeloid Leucemia

Outcome Measures

Primary Outcomes (1)

• percentage of leukemic blasts coexpressing P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2)

  Preliminary in vitro data show that the percentage of blasts coexpressing PGP+MRP+GST+BCL2 is 15% after in vitro chemotherapy. To verify these data in relapsed/refractory patients, the investigators will evaluate the percentage of patients with in vivo leukemic blasts coexpressing PGP+MRP+GST+BCL2 at \>15% post-chemotherapy.

  36 months

Secondary Outcomes (1)

• percentage of P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2) coexpression in leukemic blasts

  36 months

Study Arms (1)

Patient with acute myeloid leukemia

OTHER

Adult patient with acute myeloid for whom an additionnal 20 mL of blood will be collected.

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

Patients will be seen in hospital as part of their routine care, during which a blood test will be prescribed. On this occasion, an additional 20 mlof blood will be collected for research purposes.

Patient with acute myeloid leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Patient who has received information about the study and has not expressed opposition,
• Patients who are beneficiaries of a social security plan,
• Patient with relapsed or refractory acute myeloid leukemia, whatever the previous treatment, the therapeutic line and the time between the previous treatment and the relapse.

You may not qualify if:

• Persons who do not understand the French language if there is no translator available to translate for them.
• Absence of circulating blastosis.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Régis Costello, Professor

  Assitance Public - Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

clement PIERRE, PhD

CONTACT

+33491435796; clement.pierre@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-03