Status:
TERMINATED
ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
Lead Sponsor:
Gilead Sciences
Conditions:
Fungal Infection
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
Due to the poor outcome of patients with invasive fungal infections (IFI), a more effective prevention of these infections in such patients is wanted. These experiences in intensively treated elderly ...
Detailed Description
This is a multi-center, pilot, prospective, open label study. Approximately 20 patients will be recruited in 10 to 15 centers. The patient group will be the following: Elderly patients (≥ 55 years) ...
Eligibility Criteria
Inclusion
- Male or female patients
- Patients with acute lymphoblastic leukemia (ALL) undergoing first induction chemotherapy within the GMALL-Elderly 1/2003 protocol
- Females of childbearing potential (less than 2 years post-menopausal) must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline
- Understanding of the study's rationale and procedures documented in the patient's informed consent
- Ability and agreement to comply with all study requirements
- Patient willing to attend hospital appointments for each visit (infusions will be performed in hospital, under strict medical supervision).
Exclusion
- Known hypersensitivity to amphotericin B or LAMB or any of its constituents, in particular known history of anaphylactic reaction to amphotericin B or LAMB or any of its constituents
- Signs or symptoms of IFI or previous proven or probable IFI in the medical history
- Evidence for pulmonary infiltrates in chest CT and/or x-ray of the chest (only when a chest CT/x-ray is done at baseline)
- Estimated creatinine clearance (ECC) ≤ 60 mL/min (Cockcroft-Gault); in such cases the body surface adjusted Modification Diet in Renal Disease (MDRD) glomerular filtration rate (GFRMDRD) should be calculated. If the body surface adjusted GFRMDRD is above 60 mL/min, the patient can be included.
- Patient with moderate or severe liver disease as defined by AST, ALT or alkaline phosphatase (AP) \> 5 times the upper limit of normal (ULN), or bilirubin \> 3 times ULN
- Patients who are unlikely to survive more than 1 month
- Febrile patients (≥ 38.5°C)
- Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
- Any severe co-morbidity other than the underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the patient's safety
- Patients previously included in this study
- Patients who have taken any investigational drug within the last 30 days prior to inclusion except drugs used according to the GMALL-Elderly/2003 protocol
- Patients who participate in another clinical trial except anti-cancer trials
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00386997
Start Date
November 1 2006
End Date
September 1 2007
Last Update
August 21 2007
Active Locations (1)
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1
Gilead Sciences GmbH
Martinsried/Munich, Germany, 82152