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

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: Biological analyses

• Registration Number: NCT03234985
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute myeloid leukemia patients	Biological analyses	Patients over 18 years with acute myeloid leukemia

Primary Outcome Measures

Name	Time	Method
Complete remission	30 days	Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.

Trial Locations

Locations (1)

Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON; 🇫🇷 Pierre-Bénite, France