Study of Dosage Individualisation for the Treatment of Ac... | NCT00969891

Studies
Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

NCT00969891

Sponsor

Mikkel Krogh-Madsen

Status

Completed

Last Update Posted

Aug 25, 2011Estimated

Enrollment

23Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia

Interventions

PK-PD analysis

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT nummer 2008-008165-35

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Aug 2011Actual

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2011

Last Update Posted Date

Aug 25, 2011Estimated

Name	Class
Rigshospitalet, Denmark	OTHER
Herlev Hospital	OTHER

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AML patients in induction treatment			Other: PK-PD analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PK-PD analysis	Other	The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.	AML patients in induction treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult men and women with newly diagnosed acute myeloid leukemia

Exclusion Criteria:

under age 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients with acute myeloid leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ove J Nielsen, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Hematology clinic		Copenhagen		2100	Denmark
Herlev Hospital, Hematology Clinic

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided