Acute Myeloid LeukemiaNCT00969891
Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by Mikkel Krogh-Madsen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- PK-PD analysis
- How many people
- 23 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with acute myeloid leukemia
Who may be able to join
- adult men and women with newly diagnosed acute myeloid leukemia
Who cannot join
- under age 18 years
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, Hematology clinic
Copenhagen, 2100
Herlev Hospital, Hematology Clinic
Herlev, 2730
About this study
Official title: Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- PK-PD analysis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK-PD analysisOther
The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| AML patients in induction treatment | Not described Receives: Other: PK-PD analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant covariates from the PK study
Measured: after complete analysis of data
Secondary outcomes (1)
Amount of the three drugs in patient plasma samples
Measured: within 3 months of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startSep 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Krogh-Madsen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital
- Responsible party
- Sponsor-investigator, Mikkel Krogh-Madsen, University of Copenhagen
- Investigators
- Ove J Nielsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969891
- Sponsor's protocol ID
- AMLPKPD-20081127
- Other IDs
- EudraCT nummer 2008-008165-35
- Status last verified
- Aug 2011
- First submitted
- 28 Aug 2009
- Last updated
- 25 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00969891
- Acronym / sponsor ID
- AMLPKPD-20081127
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mikkel Krogh-MadsenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital
- Study start
- Sep 2009
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients in induction treatment | – | Other: PK-PD analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with acute myeloid leukemia
Key inclusion criteria (1 listed)
- adult men and women with newly diagnosed acute myeloid leukemia
Key exclusion criteria (1 listed)
- under age 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PK-PD analysisThe danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention. | Other | AML patients in induction treatment |
Primary outcome
significant covariates from the PK study
Time frame: after complete analysis of data
1 secondary outcome
Amount of the three drugs in patient plasma samples
Time frame: within 3 months of sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
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RecruitingPhase 2
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ove J Nielsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Mikkel Krogh-Madsen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant covariates from the PK study (time frame: after complete analysis of data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2011.