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

NCT03234985 | Completed

• 1 other identifier: 69HCL17_0351
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete remission

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

  30 days

Study Arms (1)

acute myeloid leukemia patients

Patients over 18 years with acute myeloid leukemia

Biological: Biological analyses

Interventions

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.

acute myeloid leukemia patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients or healthy volunteers over 18 years with acute myeloid leukemia (except acute myeloid leukemia3)

You may qualify if:

• 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

You may not qualify if:

• \- patients with acute myeloid leukemia 3
• adults without known hematological disease,
• adults who received the information and did not object to participate in the study
• \- Volunteers with known hematological disease.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: July 1, 2017
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)