Phase 3
N=355
Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia
Invasive Fungal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01259713 ↗Enrolled (actual)
355
Serious AEs
33.0%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL) — 7.9; 11.7 percentage of participants — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal amphotericin B (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL) |
7.9; 11.7 | 0.24 |
| SECONDARY Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader |
20.2; 27.0 | 0.15 |
| SECONDARY Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator |
11.0; 10.8 | 0.97 |
| SECONDARY Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB. |
NA; NA | 0.33 |
| SECONDARY Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy |
16.2; 21.6 | 0.22 |
| SECONDARY Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB. |
0.9; 0 | 0.32 |
| SECONDARY Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator. |
0.9; 0 | 0.32 |
| SECONDARY Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy |
50; 55 | 0.69 |
| SECONDARY Percentage of Participants With Complete Remission at the End of Remission Induction |
72.8; 79.3 | 0.20 |
Summary
The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at least 10 days of neutropenia defined as an absolute neutrophil count 2 × the upper limit of the normal range (ULN)
- Grade 3 Liver function test results: alanine aminotransferase or aspartate aminotransferase > 5 × ULN; total bilirubin > 2.5 x ULN
- Any severe co morbidity other than underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the subject's safety
- Subjects who have taken any investigational drug in the last 30 days prior to screening, with the exception of ALL chemotherapy investigational products being used as part of the subject's current ALL treatment protocol
- Pregnant or nursing females
- Subjects with a prior history of a malignancy that was treated with a myeloablative chemotherapy regimen are NOT eligible for this study.
Data sourced from ClinicalTrials.gov (NCT01259713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.