Single Cell Acute Leukemia Analysis

NCT06906978 — Not applicable, Not yet recruiting, 40 participants, Assistance Publique Hopitaux De Marseille

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Registry	NCT06906978, acronym SCALA
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	40 (Estimated)
Sponsor	Assistance Publique Hopitaux De Marseille (Other)
Conditions	Acute Myeloid Leucemia
Interventions	blood sampling (Procedure)
Dates	start 2025-07-31 (estimated), primary completion 2028-07-31 (estimated), completion 2029-07-31 (estimated), first posted 2025-04-02, last updated 2025-04-10

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patient with acute myeloid leukemia	Other	Procedure: blood sampling	Adult patient with acute myeloid for whom an additionnal 20 mL of blood will be collected.

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.

+Outcome measures

Primary outcomes

percentage of leukemic blasts coexpressing P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2) [36 months]: 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.

Secondary outcomes

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]: Mean percentages of PGP+MRP+GST+BCL2 co-expression in leukemic blasts from patients with relapsed or refractory acute myeloid leukemia.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

+Investigators

Régis Costello, Professor, Principal investigator, Assitance Public - Hôpitaux de Marseille