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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014