PROPHYSOME: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia
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|ClinicalTrials.gov Identifier: NCT00362544|
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Ambisome||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia|
|Study Start Date :||October 2003|
|Estimated Study Completion Date :||March 2006|
- The primary endpoint will be the safety defined by the incidence of adverse events occurring during the course of prophylaxis treatment (4 weeks for AL patients and 8 weeks for SCT patients).
- The secondary endpoints for assessing efficacy will be the following:
- Incidence of probable or proven invasive fungal infection according to EORTC-MSG 35 criteria within the12 weeks following the initiation of prophylaxis treatment.
- Incidence of fever of unknown origin requiring empirical antifungal treatment within 12 weeks after trial initiation.
- Incidence of superficial fungal infections within 3 months after trial initiation.
- Time differential for commencement of empirical antifungal treatment measured within 3 months after trial initiation.
- Evidence of colonisation by fungal organisms observed within 3 months after trial initiation.
- Survival rate at the end of treatment and incidence of mortality related to fungal infection within 12 weeks and 24 weeks after study drug initiation.
- Renal toxicity
- The incidence and grade of nephrotoxicity will be assessed.
- The incidence and grade hepatotoxicity will be assessed.
- Patients whose AST or ALT becomes > 10 times the ULN will be withdrawn from the study.
- Ionic analysis
- Hypokalaemia: its incidence and grade will be evaluated. Potassium supplements received by the patient will be recorded in the Case Report Form.
- Hypomagnesaemia: its incidence and grade will be evaluated as well.
- Laboratories used by both sites will provide a list of their reference ranges.
- Ionic disorders should be corrected throughout the trial.
- Cardiovascular toxicity
- The most commonly reported cardiovascular adverse events are rhythm disorders. There is a risk of seeing their incidence increase if the infusion is given too quickly.
- Vital signs and ECG will be monitored throughout the trial.
- Patients will be withdrawn from the trial, if in the investigator's opinion, further participation may put them at risk.
- General safety
- All adverse events occurring during the trial will be reported in the CRFs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362544
|Paris, France, 75015|
|Study Director:||Lamine Mahi, MD||Gilead Sciences|