Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)NCT01420562
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- blood sampling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Mar 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
Who may be able to join
- Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections
Who cannot join
- Gastroparesis
- Vomiting or diarrhea within 2 hours after intake of posaconazole
- Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
Isabel Spriet, Pharm.D. contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Kim Vanstraelen, R.Ph.
Isabel Spriet, Pharm.D.
About this study
The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
- Being tested
- blood sampling
- Keywords
- allogeneic HSCT, posaconazole, prophylaxis, mucositis, pharmacokinetics
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole oral suspension | One group of patients will receive posaconazole oral suspension as prophylactic agent.
Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis. Receives: Procedure: blood sampling | |
| Posaconazole oral tablet | Once the oral tablet is available for adminstration to patients, a second group of patients will receive these tablets as prophylactic agent.
Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
Measured: Day 0 (day of transplantation), day +7, day +14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Vanstraelen, R.Ph., Principal investigator, Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420562
- Sponsor's protocol ID
- ML7267
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2011
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
- ClinicalTrials.gov ID
- NCT01420562
- Acronym / sponsor ID
- ML7267
- Keywords
- allogeneic HSCT, posaconazole, prophylaxis, mucositis, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Aug 2011 (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 goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posaconazole oral suspension | – | Procedure: blood samplingOne group of patients will receive posaconazole oral suspension as prophylactic agent. Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis. |
| Posaconazole oral tablet | – | Procedure: blood samplingOnce the oral tablet is available for adminstration to patients, a second group of patients will receive these tablets as prophylactic agent. Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
Key inclusion criteria (1 listed)
- Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections
Key exclusion criteria (4 listed)
- Gastroparesis
- Vomiting or diarrhea within 2 hours after intake of posaconazole
- Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
- Age under 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 |
|---|---|---|
| blood samplingDuring posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis. | Procedure or surgery | Posaconazole oral suspension, Posaconazole oral tablet |
Primary outcome
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis
Time frame: Day 0 (day of transplantation), day +7, day +14
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
Isabel Spriet, Pharm.D. contact
Kim Vanstraelen, R.Ph. principal investigator
Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Vanstraelen, R.Ph. ((+32) (0)16342339, kim.vanstraelen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis (time frame: Day 0 (day of transplantation), day +7, day +14). 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 15 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.