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NCT Number: NCT06906978

Single Cell Acute Leukemia Analysis

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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Key information

Conditions

Acute Myeloid Leucemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)

    Time frame: 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

  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

    Time frame: 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

clement PIERRE, PhD

CONTACT

[email protected]

+33491435796

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: SCALA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 2, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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