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

Acute Myeloid Leukemia Clinical Trial

— NUCLARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234985
• Other study ID #: 69HCL17_0351
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
France	Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission	Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.	30 days