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Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969891
First Posted: September 1, 2009
Last Update Posted: August 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Information provided by (Responsible Party):
Mikkel Krogh-Madsen, University of Copenhagen
  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:


Further study details as provided by Mikkel Krogh-Madsen, University of Copenhagen:

Primary Outcome Measures:
  • significant covariates from the PK study [ Time Frame: after complete analysis of data ]

Secondary Outcome Measures:
  • Amount of the three drugs in patient plasma samples [ Time Frame: within 3 months of sampling ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 28, 2009
First Posted: September 1, 2009
Last Update Posted: August 25, 2011
Last Verified: August 2011

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