Antifungal prophylaxis MedDRA version: 8.1 Level: PT Classification code 10049085 Term: Antifungal prophylaxis
Conditions
Interventions
Trade Name: AmBisome
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 8000078822
Other descriptive name: AMPHOTERICINE B, LIPOSOME
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Gilead Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients • Patients with 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 rational 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) • Written informed consent must be obtained before any study protocol-related procedure is carried out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 the inclusion except drugs used according to the GMALL-Elderly/2003 protocol • Patients who participate in another clinical trial except anti-cancer trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety profile of a prophylactic antifungal LAMB treatment of 7 mg/kg, administered as a weekly intravenous infusions over two hours, during induction treatment of acute lymphoblastic leukemia of elderly patients undergoing chemotherapy with GMALL-Elderly 1/2003 protocol for four weeks.;Secondary Objective: • Incidence and time to onset of possible, probable or proven IFI according to EORTC-MSG criteria within the 12 weeks following the initiation of prophylaxis treatment. • IFI free time as % of follow-up time • The incidence of pulmonary infiltrates within 12 weeks following initiation of prophylaxis. • The need for additional systemic antifungal therapy within 12 weeks following initiation of prophylaxis. • The survival rate and incidence of mortality related to fungal infection at the end of prophylaxis treatment and within 12 weeks after prophylaxis treatment initiation.;Primary end point(s): The primary objective is to characterize the safety profile for the prophylaxis treatment course. This will be achieved by descriptive statistics on adverse events and clinical laboratory data. No statistical tests of significance are planned. | — |
Countries
Germany
Outcome results
None listed