Hematopoietic Stem Cell TransplantationPhase 2NCT00148148
A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation
A Phase 2 study testing caspofungin and liposomal amphotericin B in people with Hematopoietic Stem Cell Transplantation and Fungus Diseases, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Fungus Diseases
- What is being tested?
- caspofungin and liposomal amphotericin B
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Dec 2007
- 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
- Adults (> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes [ANC]: < or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
- Patients with persistent or recurrent fever (oral temperature > or = 38.0°C) and granulocytopenia (absolute neutrophil count < or = 500/µL) and adequate antibacterial therapy for > or = 36-48 hours, who need empirical antimycotic therapy
- Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
- Sufficient renal and hepatic function
- Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
- Availability of written informed consent from the patient or respectively from the legal representative after prior information
Who cannot join
- Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
- Pregnant or nursing patients
- Patients with pathological functional renal or hepatic parameters
- Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
- Hemodynamically unstable patients with a life expectancy of less than 5 days
- Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
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- Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
- Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient
- Prior inclusion in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
KKS Münster University Hospital
Münster, North Rhine-Westphalia, 48145
About this study
Official title: Phase II Randomised Study of the Safety, Efficacy and Pharmacokinetics of Caspofungin (CAS), Liposomal Amphotericin B (LAMB) or the Combination of Caspofungin With Liposomal Amphotericin B for Patients After Stem-Cell Transplantation
The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.
Read the detailed description
This is an open, randomised, three-arm multicenter phase II clinical trial investigating the safety, tolerance and plasma pharmacokinetics of caspofungin, liposomal amphotericin B and the combination of both agents as empirical antifungal therapy in adult patients following allogeneic hematopoietic stem cell transplantation.
Eligible patients are those with profound granulocytopenia (≤ 500 neutrophil granulocytes) and persistent or recurrent fever despite broad-spectrum antibacterial therapy of a minimum of 36-48 hours duration. Patients are stratified according to the type of the transplantation (human leukocyte antigen [HLA] matched/related versus HLA-mismatched/unrelated) and randomized into one of the following treatment arms: Caspofungin alone (50 mg/day with a loading dose of 70 mg on day 1), liposomal amphotericin B alone (3 mg/kg/day), or the combination of caspofungin and liposomal amphotericin B (similar dosages as in the single-drug treatment arms).
Caspofungin and liposomal amphotericin B are administered once daily as an intravenous infusion. Serial plasma samples for determination of pharmacokinetic parameters are collected on days one and four of treatment. Safety and tolerance of the randomised intervention are evaluated daily, following the last dose of study drug and at 14 days after last dose of study drug according to current NCI-CTC criteria. Antifungal efficacy and survival are evaluated following the last dose of study drug and at 14 days after the last dose of study drug.
Treatment with study drug is continued until either:
- treatment limiting intolerance or toxicity;
- hematopoietic engraftment (≥ 500 neutrophil granulocytes on three consecutive days) and defervescence; or
- the occurrence of a probable or proven invasive fungal infection using current EORTC/MSG criteria.
Febrile granulocytopenic patients with probable or proven invasive fungal infections are not eligible for this study. Patients who develop a probable or proven breakthrough infection are taken off study and receive standard therapy. Breakthrough infections are defined as probable or proven invasive fungal infections that occur during treatment with study medication.
Twenty-five patients with a minimum duration of treatment of four days will be randomised per study arm. Patients who receive at least one dose of study drug are eligible for analysis of safety, tolerance and pharmacokinetics. For the analysis of the secondary endpoints of antifungal efficacy and survival, two separate cohorts will be analysed. These include:
- patients who received at least one dose of study drug; and
- patients who received ≥ four doses of study drug.
- Being tested
- caspofungin, liposomal amphotericin B
- Keywords
- Hematopoietic Stem Cell Transplantation, Caspofungin, Liposomal Amphotericin B
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
liposomal amphotericin BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin with liposomal amphotericin B in accordance with NCI-CTC toxicity
Secondary outcomes (3)
Pharmacokinetics and recording of the dose-intensity of caspofungin and liposomal amphotericin B in the setting of allogeneic stem cell transplantation
Examination of pharmacokinetical interactions between caspofungin and liposomal amphotericin B
Recording of the efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin and liposomal amphotericin B in the case of empirical antimycotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMay 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Gilead Sciences
- Investigators
- Andreas Groll, M.D., Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148148
- Sponsor's protocol ID
- KKS-MS-005-KMT-10/03
- Other IDs
- BfArM 4021825
- Status last verified
- Jan 2007
- First submitted
- 6 Sep 2005
- Last updated
- 16 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised Study of the Safety, Efficacy and Pharmacokinetics of Caspofungin (CAS), Liposomal Amphotericin B (LAMB) or the Combination of Caspofungin With Liposomal Amphotericin B for Patients After Stem-Cell Transplantation
- ClinicalTrials.gov ID
- NCT00148148
- Acronym / sponsor ID
- KKS-MS-005-KMT-10/03
- Keywords
- Hematopoietic Stem Cell Transplantation, Caspofungin, Liposomal Amphotericin B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Gilead Sciences
- Study start
- May 2004
- Study completion
- Dec 2007
- First posted
- 7 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 study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.
Detailed description
This is an open, randomised, three-arm multicenter phase II clinical trial investigating the safety, tolerance and plasma pharmacokinetics of caspofungin, liposomal amphotericin B and the combination of both agents as empirical antifungal therapy in adult patients following allogeneic hematopoietic stem cell transplantation.
Eligible patients are those with profound granulocytopenia (≤ 500 neutrophil granulocytes) and persistent or recurrent fever despite broad-spectrum antibacterial therapy of a minimum of 36-48 hours duration. Patients are stratified according to the type of the transplantation (human leukocyte antigen [HLA] matched/related versus HLA-mismatched/unrelated) and randomized into one of the following treatment arms: Caspofungin alone (50 mg/day with a loading dose of 70 mg on day 1), liposomal amphotericin B alone (3 mg/kg/day), or the combination of caspofungin and liposomal amphotericin B (similar dosages as in the single-drug treatment arms).
Caspofungin and liposomal amphotericin B are administered once daily as an intravenous infusion. Serial plasma samples for determination of pharmacokinetic parameters are collected on days one and four of treatment. Safety and tolerance of the randomised intervention are evaluated daily, following the last dose of study drug and at 14 days after last dose of study drug according to current NCI-CTC criteria. Antifungal efficacy and survival are evaluated following the last dose of study drug and at 14 days after the last dose of study drug.
Treatment with study drug is continued until either:
- treatment limiting intolerance or toxicity;
- hematopoietic engraftment (≥ 500 neutrophil granulocytes on three consecutive days) and defervescence; or
- the occurrence of a probable or proven invasive fungal infection using current EORTC/MSG criteria.
Febrile granulocytopenic patients with probable or proven invasive fungal infections are not eligible for this study. Patients who develop a probable or proven breakthrough infection are taken off study and receive standard therapy. Breakthrough infections are defined as probable or proven invasive fungal infections that occur during treatment with study medication.
Twenty-five patients with a minimum duration of treatment of four days will be randomised per study arm. Patients who receive at least one dose of study drug are eligible for analysis of safety, tolerance and pharmacokinetics. For the analysis of the secondary endpoints of antifungal efficacy and survival, two separate cohorts will be analysed. These include:
- patients who received at least one dose of study drug; and
- patients who received ≥ four doses of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes [ANC]: < or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
- Patients with persistent or recurrent fever (oral temperature > or = 38.0°C) and granulocytopenia (absolute neutrophil count < or = 500/µL) and adequate antibacterial therapy for > or = 36-48 hours, who need empirical antimycotic therapy
- Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
- Sufficient renal and hepatic function
- Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
Key exclusion criteria (9 listed)
- Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
- Pregnant or nursing patients
- Patients with pathological functional renal or hepatic parameters
- Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
- Hemodynamically unstable patients with a life expectancy of less than 5 days
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 |
|---|---|---|
| caspofungin | Drug | – |
| liposomal amphotericin B | Drug | – |
Primary outcome
Safety and efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin with liposomal amphotericin B in accordance with NCI-CTC toxicity
3 secondary outcomes
Pharmacokinetics and recording of the dose-intensity of caspofungin and liposomal amphotericin B in the setting of allogeneic stem cell transplantation
Examination of pharmacokinetical interactions between caspofungin and liposomal amphotericin B
Recording of the efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin and liposomal amphotericin B in the case of empirical antimycotic therapy
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 16 Jan 2008.
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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.
Andreas Groll, M.D. principal investigator
University Hospital Muenster
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 caspofungin and liposomal amphotericin B in people with Hematopoietic Stem Cell Transplantation and Fungus Diseases, run by University Hospital Muenster at 1 site 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 6 inclusion and 9 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 16 Jan 2008. 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 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 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?
Safety and efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin with liposomal amphotericin B in accordance with NCI-CTC toxicity. 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 16 Jan 2008; AzTrials last refreshed its copy on 7 Nov 2026.