Acute Graft Versus Host Disease Grade II-IVPhase 2MATADORNCT02172768
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
A Phase 2 study testing alternate dosing, daily dosing and micafungin in people with Acute Graft Versus Host Disease Grade II-IV and Allogeneic Stem Cell Transplant, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial summary
The primary objective of this trial is as follows: To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia
- What is being tested?
- alternate dosing, daily dosing and micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to Jul 2016
- Phase
- Phase 2
- 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
- Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
- Subject is at least 18 of age on the day of providing informed consent.
- Has no signs or symptoms of invasive fungal disease
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
- Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
- Subject is able and willing to sign the Informed Consent before screening evaluations.
Who cannot join
- Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature of the trial and the procedures required.
- Has not previously participated in this trial.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease.
The primary objective of this trial is as follows:
To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.
The secondary objective of this trial is as follows:
To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population
Read the detailed description
Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.
It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.
- Conditions
- Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia, Myelo Dysplastic Syndrome
- Being tested
- alternate dosing, daily dosing, micafungin
- Keywords
- pharmacokinetics, alternate dosing, micafungin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alternate dosingOther
Also called micafungin
treatment for 8 days with intravenous micafungin twice weekly
daily dosingOther
micafungin daily for 8 days
micafunginDrug
| Study group | Role | What they receive |
|---|---|---|
| alternate dosing | Experimental | treatment for 8 days with intravenous micafungin twice weekly Receives: Other: alternate dosing; Drug: micafungin |
| daily dosing | Active comparator | micafungin daily for 8 days Receives: Other: daily dosing; Drug: micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve
Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.
Measured: day 4 and day 8
Secondary outcomes (2)
population PK model
to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting
Measured: Day 4 and Day 8
adverse events
number and severity of adverse events will be recorded during the study and both treatment regimens will be compared
Measured: day 1- 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Graft Versus Host Disease Grade II-IVStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Brüggemann, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172768
- Sponsor's protocol ID
- MATADOR
- Acronym
- MATADOR
- Status last verified
- Dec 2020
- First submitted
- 20 Jun 2014
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Muilwijk EW, Maertens JA, van der Velden WJFM, Ter Heine R, Colbers A, Burger DM, Andes D, Theunissen K, Blijlevens NMA, Bruggemann RJM. Pharmacokinetics of extended dose intervals of micafungin in haematology patients: optimizing antifungal prophylaxis. J Antimicrob Chemother. 2018 Nov 1;73(11):3095-3101. doi: 10.1093/jac/dky324.
PubMed 30137340
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease.
- ClinicalTrials.gov ID
- NCT02172768
- Acronym / sponsor ID
- MATADOR / MATADOR
- Conditions
- Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia, Myelo Dysplastic Syndrome
- Keywords
- pharmacokinetics, alternate dosing, micafungin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Jun 2014 (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 primary objective of this trial is as follows:
To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.
The secondary objective of this trial is as follows:
To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population
Detailed description
Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.
It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alternate dosing | Experimental | Other: alternate dosing, Drug: micafungintreatment for 8 days with intravenous micafungin twice weekly |
| daily dosing | Active comparator | Other: daily dosing, Drug: micafunginmicafungin daily for 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
- Subject is at least 18 of age on the day of providing informed consent.
- Has no signs or symptoms of invasive fungal disease
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
Key exclusion criteria (4 listed)
- Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature of the trial and the procedures required.
- Has not previously participated in this trial.
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 |
|---|---|---|
| alternate dosingAlso: micafungintreatment for 8 days with intravenous micafungin twice weekly | Other | alternate dosing |
| daily dosingmicafungin daily for 8 days | Other | daily dosing |
| micafungin | Drug | alternate dosing, daily dosing |
Primary outcome
area under the curve
Time frame: day 4 and day 8
Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.
2 secondary outcomes
population PK model
Time frame: Day 4 and Day 8
adverse events
Time frame: day 1- 11
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 8 Dec 2020.
- Results publication: PubMed 30137340Muilwijk EW, Maertens JA, van der Velden WJFM, Ter Heine R, Colbers A, Burger DM, Andes D, Theunissen K, Blijlevens NMA, Bruggemann RJM. Pharmacokinetics of extended dose intervals of micafungin in haematology patients: optimizing antifungal prophylaxis. J Antimicrob Chemother. 2018 Nov 1;73(11):3095-3101. doi: 10.1093/jac/dky324.
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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.
Roger Brüggemann principal investigator
Radboud University Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alternate dosing, daily dosing and micafungin in people with Acute Graft Versus Host Disease Grade II-IV and Allogeneic Stem Cell Transplant, run by Radboud University Medical Center at 2 sites in 2 countries.
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 7 inclusion and 4 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 8 Dec 2020. 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 Belgium, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
area under the curve (time frame: day 4 and day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02172768, which also lists 1 linked publication.
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 8 Dec 2020.