Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

August 24, 2011 updated by: Mikkel Krogh-Madsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Hematology clinic
      • Herlev, Denmark, 2730
        • Herlev Hospital, Hematology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients with acute myeloid leukemia

Description

Inclusion Criteria:

  • adult men and women with newly diagnosed acute myeloid leukemia

Exclusion Criteria:

  • under age 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AML patients in induction treatment
Other: PK-PD analysis
The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
significant covariates from the PK study
Time Frame: after complete analysis of data
after complete analysis of data

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of the three drugs in patient plasma samples
Time Frame: within 3 months of sampling
within 3 months of sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mikkel Krogh-Madsen

Collaborators

Rigshospitalet, Denmark
Herlev Hospital

Investigators

  • Principal Investigator: Ove J Nielsen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2011

Last Update Submitted That Met QC Criteria

August 24, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLPKPD-20081127
  • EudraCT nummer 2008-008165-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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