Leukemia, Myelocytic, AcutePhase 3NCT00152594
Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
A Phase 3 study testing voriconazole in people with Leukemia, Myelocytic, Acute, run by University of Cologne at 3 sites in Germany.
Trial summary
The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML). Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelocytic, Acute
- What is being tested?
- voriconazole
- How many people
- 150 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2004to Jan 2006
- Phase
- Phase 3
- 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
Who may be able to join
- Newly diagnosed or relapsed, de novo or secondary AML
- First induction chemotherapy cycle
- Expected neutropenic phase of a minimum duration of 10 days
- Age >= 18 years
- Legally signed consent form
Who cannot join
- Known proven, probable or possible invasive fungal infection at randomization or in patient history
- Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
- Any current fever unless explained by non-infectious causes
- Antibacterial prophylaxis other than TMP/SMX
- Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
- Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
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- Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine);
- Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids).
- Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
- Concomitant therapy with absorbable antifungals
- Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
- Known hypersensitivity or other contraindication to voriconazole
- Patient is unwilling or unable to comply with the protocol.
- Diseases or disabilities preventing the patient from participating in the trial
- Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum der Universität Köln
Cologne, 50931
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, 60590
Universitätsklinikum Mannheim, Universität Heidelberg
Heidelberg, 68305
About this study
Official title: Phase III Study of Safety, Tolerance, Efficacy, Pharmacokinetics, and Costs of Therapy With Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).
Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.
- Conditions
- Leukemia, Myelocytic, Acute
- Being tested
- voriconazole
- 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.
voriconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
Secondary outcomes (11)
To determine and compare between study arms the: incidence of fever and other signs of infection
incidence and type of documented bacteremia
rate of patients with systemic open-label antifungal therapy
time to initiation of systemic open-label antifungal therapy
duration of absolute neutrophil count < 500/µl
rate and type of proven, probable and possible breakthrough invasive fungal infections
rate of patients with fever of unknown origin
incidence and severity of adverse events
trough voriconazole plasma level after day 8 of study treatment
direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
overall costs in terms of the diagnosis related groups applied to the study patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Oliver A. Cornely, MD, Principal investigator, Klinikum der Universität Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152594
- Sponsor's protocol ID
- NRA 150 0009
- Status last verified
- Nov 2006
- First submitted
- 7 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Safety, Tolerance, Efficacy, Pharmacokinetics, and Costs of Therapy With Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00152594
- Acronym / sponsor ID
- NRA 150 0009
- Conditions
- Leukemia, Myelocytic, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Jan 2006
- First posted
- 9 Sep 2005 (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 purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).
Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed or relapsed, de novo or secondary AML
- First induction chemotherapy cycle
- Expected neutropenic phase of a minimum duration of 10 days
- Age >= 18 years
- Legally signed consent form
Key exclusion criteria (15 listed)
- Known proven, probable or possible invasive fungal infection at randomization or in patient history
- Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
- Any current fever unless explained by non-infectious causes
- Antibacterial prophylaxis other than TMP/SMX
- Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
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 |
|---|---|---|
| voriconazole | Drug | – |
Primary outcome
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
11 secondary outcomes
To determine and compare between study arms the: incidence of fever and other signs of infection
incidence and type of documented bacteremia
rate of patients with systemic open-label antifungal therapy
time to initiation of systemic open-label antifungal therapy
duration of absolute neutrophil count < 500/µl
rate and type of proven, probable and possible breakthrough invasive fungal infections
rate of patients with fever of unknown origin
incidence and severity of adverse events
trough voriconazole plasma level after day 8 of study treatment
direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
overall costs in terms of the diagnosis related groups applied to the study patients
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
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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.
Oliver A. Cornely, MD principal investigator
Klinikum der Universität Köln
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing voriconazole in people with Leukemia, Myelocytic, Acute, run by University of Cologne at 3 sites in Germany.
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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo. 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 14 Nov 2006.