Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia (AmBiGuard)
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| ClinicalTrials.gov Identifier: NCT01259713 |
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Recruitment Status :
Completed
First Posted : December 14, 2010
Results First Posted : April 6, 2015
Last Update Posted : May 7, 2015
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Condition |
Invasive Fungal Disease |
| Interventions |
Drug: Liposomal amphotericin B Drug: Placebo |
| Enrollment | 355 |
Participant Flow
| Recruitment Details | Participants were enrolled at a total of 86 study sites. The first participant was screened on 13 April 2011. The last study visit occurred on 29 January 2014. |
| Pre-assignment Details | 391 participants were screened. |
| Arm/Group Title | Liposomal Amphotericin B | Placebo |
|---|---|---|
 Arm/Group Description |
Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy | Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy |
| Period Title: Overall Study | ||
| Started | 237 | 118 |
| Completed | 142 | 77 |
| Not Completed | 95 | 41 |
| Reason Not Completed | ||
| Adverse Event | 54 | 23 |
| Death Not Related to IFI | 8 | 1 |
| Investigators Discretion | 14 | 6 |
| Lack of Efficacy | 2 | 0 |
| Protocol Violation | 5 | 4 |
| Subject Withdrew Consent | 12 | 7 |
Baseline Characteristics
| Arm/Group Title | Liposomal Amphotericin B | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy | Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy | Total of all reporting groups | |
| Overall Number of Baseline Participants | 237 | 118 | 355 | |
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Baseline Analysis Population Description |
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 237 participants | 118 participants | 355 participants | |
| 44.5 (15.16) | 44.8 (17.52) | 44.6 (15.96) | ||
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 237 participants | 118 participants | 355 participants |
| ≤ 25 years | 37 | 25 | 62 | |
| > 25 to ≤ 60 years | 160 | 64 | 224 | |
| > 60 years | 40 | 29 | 69 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 237 participants | 118 participants | 355 participants | |
| Female |
98 41.4%
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58 49.2%
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156 43.9%
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| Male |
139 58.6%
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60 50.8%
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199 56.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 237 participants | 118 participants | 355 participants |
| Asian | 1 | 0 | 1 | |
| Black | 4 | 3 | 7 | |
| White | 211 | 100 | 311 | |
| Not Permitted | 17 | 15 | 32 | |
| Other | 4 | 0 | 4 | |
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 237 participants | 118 participants | 355 participants |
| Germany | 52 | 23 | 75 | |
| Italy | 41 | 25 | 66 | |
| France | 33 | 19 | 52 | |
| Belgium | 20 | 11 | 31 | |
| Spain | 21 | 7 | 28 | |
| Greece | 14 | 13 | 27 | |
| Portugal | 13 | 4 | 17 | |
| Turkey | 7 | 4 | 11 | |
| Austria | 6 | 3 | 9 | |
| Israel | 9 | 0 | 9 | |
| Switzerland | 6 | 1 | 7 | |
| Brazil | 8 | 7 | 15 | |
| Argentina | 7 | 1 | 8 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Results Point of Contact
| Name/Title: | Clinical Trial Disclosures |
| Organization: | Gilead Sciences, Inc. |
| EMail: | ClinicalTrialDisclosures@gilead.com |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01259713 |
| Other Study ID Numbers: |
GS-EU-131-0247 2010-019562-91 ( EudraCT Number ) |
| First Submitted: | December 10, 2010 |
| First Posted: | December 14, 2010 |
| Results First Submitted: | March 25, 2015 |
| Results First Posted: | April 6, 2015 |
| Last Update Posted: | May 7, 2015 |