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Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

NCT03234985 — Completed, 83 participants, Hospices Civils de Lyon

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RegistryNCT03234985, acronym NUCLARA
StatusCompleted
Study typeObservational
Enrollment83 (Actual)
SponsorHospices Civils de Lyon (Other)
ConditionsAcute Myeloid Leukemia
InterventionsBiological analyses (Biological)
Datesstart 2017-07-01, primary completion 2021-10-25, completion 2021-10-25, first posted 2017-08-01, last updated 2022-11-15
Locations1 site in France

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-Summary

Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.

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+Arms and interventions

ArmTypeInterventionsDescription
acute myeloid leukemia patientsBiological: Biological analysesPatients over 18 years with acute myeloid leukemia
  • Biological analyses (Biological): Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.

+Outcome measures

Primary outcomes

  • Complete remission [30 days]: Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Patients Inclusion Criteria:

* age over 18 years
* acute myeloid leukemia
* standard induction chemotherapy with cytarabine and daunorubicin
* patients who received the information and did not object to participate to the study

Patients Exclusion Criteria:

\- patients with acute myeloid leukemia 3

healthy volunteers Inclusion Criteria :

* adults without known hematological disease,
* adults who received the information and did not object to participate in the study

healthy volunteers Exclusion Criteria :

\- Volunteers with known hematological disease.

+Locations (1)

FacilityCityCountryStatus
Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYONPierre-BéniteFrance

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