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Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Information provided by (Responsible Party):
Mikkel Krogh-Madsen, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00969891
First received: August 28, 2009
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Myeloid Leukemia
 Other: PK-PD analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • significant covariates from the PK study [ Time Frame: after complete analysis of data ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of the three drugs in patient plasma samples [ Time Frame: within 3 months of sampling ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma samples


Enrollment: 23
Study Start Date: September 2009
Study Completion Date: August 2011
Groups/Cohorts Assigned Interventions
AML patients in induction treatment Other: PK-PD analysis
The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients with acute myeloid leukemia

Criteria

Inclusion Criteria:

  • adult men and women with newly diagnosed acute myeloid leukemia

Exclusion Criteria:

  • under age 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969891

Locations
Denmark
Rigshospitalet, Hematology clinic
Copenhagen, Denmark, 2100
Herlev Hospital, Hematology Clinic
Herlev, Denmark, 2730
Sponsors and Collaborators
Mikkel Krogh-Madsen
Rigshospitalet, Denmark
Herlev Hospital
Investigators
Principal Investigator: Ove J Nielsen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Mikkel Krogh-Madsen, PhD student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00969891     History of Changes
Other Study ID Numbers: AMLPKPD-20081127, EudraCT nummer 2008-008165-35
Study First Received: August 28, 2009
Last Updated: August 24, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013