LeukemiaPhase 2ANIDULAPKNCT01249820
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
A Phase 2 study testing anidulafungin 200 mg q48h and anidulafungin 300 mg q72h in people with Leukemia and Myelodysplastic Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndrome, Leukemia, Myeloid, Acute
- What is being tested?
- anidulafungin 200 mg q48h and anidulafungin 300 mg q72h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Jan 2013
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
- Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- 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
- Has an ALAT, ALAT, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
- Is not known to be hypersensitive to echinocandin antifungal agents
- Is managed with a quadruple central venous catheter (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 anidulafungin preparation
- Known of Positive HIV test or hepatitis B or C test in history
- History of QT time prolongation
- 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
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Anidulafungin Given Intravenously as Antifungal Prophylaxis to Recipients of an Allogeneic Haematopoietic Stem Cell Transplant Following Myeloablative Chemotherapy or Patients Receiving Intensive Chemotherapy for AML-MDS
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.
Read the detailed description
Alternate dosing strategies of echinocandin drugs might provide a better efficacy in the treatment of fungal infections as compared to the current label dosing strategy. Before conducting a controlled efficacy trial of echinocandins in haematology patients, the pharmacokinetics of these alternate dosing strategies need to be tested before bringing this idea to practice in a large randomised trial.
Therefore we want to conduct a pharmacokinetic study with anidulafungin given every 48 hours or every 72 hours. This research can be performed best in a group of patients at high risk for developing invasive fungal infections.
Recipients of an allogeneic haematopoietic stem cell transplant (HSCT) or patients receiving intensive chemotherapy for acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) are at a relatively high risk of developing invasive fungal infections and are therefore candidates for primary prophylaxis. However, the options are limited to fluconazole which affords no protection against mould infections. Amphotericin B is not considered useful because of its desoxycholate formulation has too many side effects and its lipid formulations are too expensive nor have the broad-spectrum triazoles itraconazole and voriconazole proved their value in this setting. Anidulafungin is the first of a new class of antifungal drugs quite unlike any others attacking specifically the ß 1-3 -D-glucan synthase of the cell wall. It has relatively few side effects and appears safe and effective for treating Aspergillus and Candida infections. Since these two genera account for 90% of fungal infections in HSCT recipients the drug would seem an ideal candidate for prophylaxis.
Importantly, nothing is known about the pharmacokinetics of alternate dosing regimens of anidulafungin in this patient population. Therefore a pharmacokinetic study of a homogenous cohort of patients is necessary to test the assumption, that adequate exposure is obtained with alternate dosing and that it is safe.
- Conditions
- Leukemia, Myelodysplastic Syndrome, Leukemia, Myeloid, Acute
- Being tested
- anidulafungin 200 mg q48h, anidulafungin 300 mg q72h
- Keywords
- anidulafungin, antifungal prophylaxis, allogeneic haematopoietic stem cell transplant, myeloablative chemotherapy, AML-MDS, pharmacokinetics
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anidulafungin 200 mg q48hDrug
Also called Ecalta
Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)
anidulafungin 300 mg q72hDrug
Also called Ecalta
Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages)
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages) Receives: Drug: anidulafungin 200 mg q48h |
| group B | Experimental | Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages) Receives: Drug: anidulafungin 300 mg q72h |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
comparison of pharmacokinetics of anidulafungin given once in every two days or once in every three days
Measured: two weeks per subject
Secondary outcomes (2)
adequate exposure
To determine whether adequate exposure is attained by patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS when using a q48 hour or a q72 hour dosing regimen
Measured: 2 weeks for each subject; analysis after 3 months after last subject inclusion
safety
To determine the safety of anidulafungin in the patient population
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionJan 2013
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 LeukemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R Brüggemann, PharmD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249820
- Sponsor's protocol ID
- UMCN-AKF 10.01 / SC25
- Acronym
- ANIDULAPK
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2010
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruggemann RJ, Van Der Velden WJ, Knibbe CA, Colbers A, Hol S, Burger DM, Donnelly JP, Blijlevens NM. A rationale for reduced-frequency dosing of anidulafungin for antifungal prophylaxis in immunocompromised patients. J Antimicrob Chemother. 2015 Apr;70(4):1166-74. doi: 10.1093/jac/dku477. Epub 2014 Dec 3.
PubMed 25473029
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 Anidulafungin Given Intravenously as Antifungal Prophylaxis to Recipients of an Allogeneic Haematopoietic Stem Cell Transplant Following Myeloablative Chemotherapy or Patients Receiving Intensive Chemotherapy for AML-MDS
- ClinicalTrials.gov ID
- NCT01249820
- Acronym / sponsor ID
- ANIDULAPK / UMCN-AKF 10.01 / SC25
- Conditions
- Leukemia, Myelodysplastic Syndrome, Leukemia, Myeloid, Acute
- Keywords
- anidulafungin, antifungal prophylaxis, allogeneic haematopoietic stem cell transplant, myeloablative chemotherapy, AML-MDS, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Nov 2010 (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 this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.
Detailed description
Alternate dosing strategies of echinocandin drugs might provide a better efficacy in the treatment of fungal infections as compared to the current label dosing strategy. Before conducting a controlled efficacy trial of echinocandins in haematology patients, the pharmacokinetics of these alternate dosing strategies need to be tested before bringing this idea to practice in a large randomised trial.
Therefore we want to conduct a pharmacokinetic study with anidulafungin given every 48 hours or every 72 hours. This research can be performed best in a group of patients at high risk for developing invasive fungal infections.
Recipients of an allogeneic haematopoietic stem cell transplant (HSCT) or patients receiving intensive chemotherapy for acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) are at a relatively high risk of developing invasive fungal infections and are therefore candidates for primary prophylaxis. However, the options are limited to fluconazole which affords no protection against mould infections. Amphotericin B is not considered useful because of its desoxycholate formulation has too many side effects and its lipid formulations are too expensive nor have the broad-spectrum triazoles itraconazole and voriconazole proved their value in this setting. Anidulafungin is the first of a new class of antifungal drugs quite unlike any others attacking specifically the ß 1-3 -D-glucan synthase of the cell wall. It has relatively few side effects and appears safe and effective for treating Aspergillus and Candida infections. Since these two genera account for 90% of fungal infections in HSCT recipients the drug would seem an ideal candidate for prophylaxis.
Importantly, nothing is known about the pharmacokinetics of alternate dosing regimens of anidulafungin in this patient population. Therefore a pharmacokinetic study of a homogenous cohort of patients is necessary to test the assumption, that adequate exposure is obtained with alternate dosing and that it is safe.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: anidulafungin 200 mg q48hDay 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages) |
| group B | Experimental | Drug: anidulafungin 300 mg q72hDay 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
- Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- 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
- Has an ALAT, ALAT, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
Key exclusion criteria (6 listed)
- Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- Known of Positive HIV test or hepatitis B or C test in history
- History of QT time prolongation
- History of or current abuse of drugs, alcohol or solvents
- Inability to understand the nature of the trial and the procedures required
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 |
|---|---|---|
| anidulafungin 200 mg q48hAlso: EcaltaDay 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages) | Drug | group A |
| anidulafungin 300 mg q72hAlso: EcaltaDay 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages) | Drug | group B |
Primary outcome
pharmacokinetics
Time frame: two weeks per subject
comparison of pharmacokinetics of anidulafungin given once in every two days or once in every three days
2 secondary outcomes
adequate exposure
Time frame: 2 weeks for each subject; analysis after 3 months after last subject inclusion
safety
Time frame: 3 weeks
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 25473029Bruggemann RJ, Van Der Velden WJ, Knibbe CA, Colbers A, Hol S, Burger DM, Donnelly JP, Blijlevens NM. A rationale for reduced-frequency dosing of anidulafungin for antifungal prophylaxis in immunocompromised patients. J Antimicrob Chemother. 2015 Apr;70(4):1166-74. doi: 10.1093/jac/dku477. Epub 2014 Dec 3.
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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.
R Brüggemann, PharmD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anidulafungin 200 mg q48h and anidulafungin 300 mg q72h in people with Leukemia and Myelodysplastic Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
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 8 inclusion and 6 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 1 site in 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?
pharmacokinetics (time frame: two weeks per subject). 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 NCT01249820, 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.