Fungus DiseasesPhase 2NCT00326157
PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
A Phase 2 study testing AmBisome in people with Fungus Diseases, run by Gilead Sciences at 1 site in Italy.
Trial summary
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungus Diseases
- What is being tested?
- AmBisome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2006to Nov 2009
- 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
- Male or female patients aged more than 18 years
- Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
- No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
- Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
- Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
- An understanding of the study and agreement of the patient to give written informed consent
- Ability and agreement to comply with all study requirements
- Patient willing to attend hospital appointments for each injection (infusions will be performed in the hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.
Who cannot join
- Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
- Patients undergoing cord transplantation
- Creatinine > 2.0 mg/dL
- Patient with moderate or severe liver disease as defined by AST or ALT > 5 times the upper limit of normal (ULN)
- Patients who are unlikely to survive more than 1 month
- Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
Show all 11Show fewer
- Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
- Any severe disease other than the hematological diseases described at the second point of inclusion criteria, which in the investigator's judgement may interfere with study evaluations or affect the patient's safety
- Pregnant or nursing females
- Patients previously included in this study
- Patients who have taken any investigational drug in the last 30 days prior to the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Pilot Study on Safety of Administration of 3mg/kg/Day Three Times a Week Until Day 22 (21 Days After Transplantation Day) and 7 mg/kg Weekly From Day 29 to the End of Treatment (Day 50-8th Week) of AmBisome® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.
Read the detailed description
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.
- Conditions
- Fungus Diseases
- Being tested
- AmBisome
- Keywords
- antifungal primary prophylaxis treatment, allogeneic stem-cell transplantation, antifungal primary prophylaxis treatment of high risk patients undergoing allogeneic stem-cell transplantation
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmBisomeDrug
3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AmBisome® will be administered for a duration of 8 weeks Receives: Drug: AmBisome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
Measured: Through 16 weeks
Number (%) of patients with infusion related AE
Measured: Through 16 weeks
Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)
Measured: Through 16 weeks
Overall adverse events
Measured: Through 16 weeks
Secondary outcomes (14)
Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment
Measured: Within previous 6 months
Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment
Measured: Within previous 6 months
Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment
Measured: Within previous 6 months
Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment
Measured: Within previous 6 months
Reasons for early study discontinuation
Measured: Through 16 weeks
Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6, and 12 months after the initiation of prophylaxis treatment
Measured: Within 12 months
Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment
Measured: Through 16 weeks
Time to superficial fungal infections
Measured: Through 16 weeks
Time to initiation of empirical antifungal treatment
Measured: Through 16 weeks
Time to study discontinuation
Measured: Through 16 weeks
Number of patients enrolled
Measured: Through 16 weeks
Number of patients completing the study
Measured: Through 16 weeks
Number of patients with early discontinuation
Measured: Through 16 weeks
Number of patients classified by reason for discontinuing study drug (including the study completion)
Measured: Through 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungus DiseasesStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luigi Picaro, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326157
- Sponsor's protocol ID
- GS-IT-131-0151
- Status last verified
- Feb 2010
- First submitted
- 10 May 2006
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study on Safety of Administration of 3mg/kg/Day Three Times a Week Until Day 22 (21 Days After Transplantation Day) and 7 mg/kg Weekly From Day 29 to the End of Treatment (Day 50-8th Week) of AmBisome® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation
- ClinicalTrials.gov ID
- NCT00326157
- Acronym / sponsor ID
- GS-IT-131-0151
- Conditions
- Fungus Diseases
- Keywords
- antifungal primary prophylaxis treatment, allogeneic stem-cell transplantation, antifungal primary prophylaxis treatment of high risk patients undergoing allogeneic stem-cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 May 2006 (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.
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.
Detailed description
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AmBisomeAmBisome® will be administered for a duration of 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients aged more than 18 years
- Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
- No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
- Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
- Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
Key exclusion criteria (11 listed)
- Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
- Patients undergoing cord transplantation
- Creatinine > 2.0 mg/dL
- Patient with moderate or severe liver disease as defined by AST or ALT > 5 times the upper limit of normal (ULN)
- Patients who are unlikely to survive more than 1 month
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 |
|---|---|---|
| AmBisome3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment (day 50-8th Week) of AmBisome®, IV administration | Drug | 1 |
Primary outcome
Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
Time frame: Through 16 weeks
Number (%) of patients with infusion related AE
Time frame: Through 16 weeks
Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)
Time frame: Through 16 weeks
Overall adverse events
Time frame: Through 16 weeks
14 secondary outcomes
Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment
Time frame: Within previous 6 months
Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment
Time frame: Within previous 6 months
Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment
Time frame: Within previous 6 months
Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment
Time frame: Within previous 6 months
Reasons for early study discontinuation
Time frame: Through 16 weeks
Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6, and 12 months after the initiation of prophylaxis treatment
Time frame: Within 12 months
Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment
Time frame: Through 16 weeks
Time to superficial fungal infections
Time frame: Through 16 weeks
Time to initiation of empirical antifungal treatment
Time frame: Through 16 weeks
Time to study discontinuation
Time frame: Through 16 weeks
Number of patients enrolled
Time frame: Through 16 weeks
Number of patients completing the study
Time frame: Through 16 weeks
Number of patients with early discontinuation
Time frame: Through 16 weeks
Number of patients classified by reason for discontinuing study drug (including the study completion)
Time frame: Through 16 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 12 Feb 2010.
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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.
Luigi Picaro, MD study director
Gilead Sciences
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 AmBisome in people with Fungus Diseases, run by Gilead Sciences at 1 site in Italy.
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 11 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 12 Feb 2010. 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 Italy. 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 tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs) (time frame: Through 16 weeks). The study lists 4 primary outcomes in all. 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 12 Feb 2010.