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

NCT ID: NCT03234985

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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acute myeloid leukemia patients

Patients over 18 years with acute myeloid leukemia

Biological analyses

Intervention Type 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.

Interventions

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Biological analyses

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


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

Exclusion Criteria

\- patients with acute myeloid leukemia 3


\- Volunteers with known hematological disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0351

Identifier Type: -

Identifier Source: org_study_id

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