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Completed

NCT Number: NCT03234985

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

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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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Complete remission

    Time frame: 30 days

    Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: NUCLARA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2017
Registry last updated
Nov 15, 2022

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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