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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03234985
Acronym
NUCLARA
Enrollment
83
Registered
2017-08-01
Start date
2017-07-01
Completion date
2021-10-25
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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.

Interventions

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Complete remission30 daysPrimary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026