Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00969891

Enrollment

Registered

2009-09-01

Start date

2009-09-30

Completion date

2011-08-31

Last updated

2011-08-25

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

The present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.

Interventions

OTHERPK-PD analysis

The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult men and women with newly diagnosed acute myeloid leukemia

Exclusion criteria

* under age 18 years

Design outcomes

Primary

Measure	Time frame
significant covariates from the PK study	after complete analysis of data

Secondary

Measure	Time frame
Amount of the three drugs in patient plasma samples	within 3 months of sampling

Countries

Denmark

Outcome results

None listed

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