Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

NCT ID: NCT00969891

Last Updated: 2011-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AML patients in induction treatment

PK-PD analysis

Intervention Type OTHER

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

Interventions

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PK-PD analysis

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult men and women with newly diagnosed acute myeloid leukemia

Exclusion Criteria

* under age 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Mikkel Krogh-Madsen

OTHER

Sponsor Role lead

Responsible Party

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Mikkel Krogh-Madsen

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ove J Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Hematology clinic

Copenhagen, , Denmark

Site Status

Herlev Hospital, Hematology Clinic

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EudraCT nummer 2008-008165-35

Identifier Type: -

Identifier Source: secondary_id

AMLPKPD-20081127

Identifier Type: -

Identifier Source: org_study_id

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