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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Netherlands1 site

  • Radboud University Nijmegen Medical Centre

    Nijmegen

Other trials in Netherlands

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.

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 groups in NCT01249820
Study groupRoleWhat they receive
group AExperimentalDay 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)
Receives: Drug: anidulafungin 200 mg q48h
group BExperimentalDay 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.

  1. 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)

  1. 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

  2. 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.

  1. First posted30 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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)
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

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.

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