RT Journal Article
T1 Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia.
A1 Cornely, Oliver A
A1 Leguay, Thibaut
A1 Maertens, Johan
A1 Vehreschild, Maria J G T
A1 Anagnostopoulos, Achilles
A1 Castagnola, Carlo
A1 Verga, Luisa
A1 Rieger, Christina
A1 Kondakci, Mustafa
A1 Härter, Georg
A1 Duarte, Rafael F
A1 Allione, Bernardino
A1 Cordonnier, Catherine
A1 Heussel, Claus Peter
A1 Morrissey, C Orla
A1 Agrawal, Samir G
A1 Donnelly, J Peter
A1 Bresnik, Mark
A1 Hawkins, Michael J
A1 Garner, Will
A1 Gökbuget, Nicola
A1 AmBiGuard Study Group, 
AB To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL). In a double-blind multicentre Phase 3 study, patients received prophylactic liposomal amphotericin B (L-AMB) at 5 mg/kg intravenously or placebo twice weekly in a 2:1 random allocation during remission-induction treatment. The primary endpoint was the development of proven or probable IFD. Secondary endpoints included those focused on the safety and tolerability of prophylactic L-AMB. Three hundred and fifty-five patients from 86 centres in Europe and South America received at least one dose of L-AMB ( n =  237) or placebo ( n =  118). Rates of proven and probable IFD assessed independently were 7.9% (18/228) in the L-AMB group and 11.7% (13/111) in the placebo group ( P  =   0.24). Rates of possible IFD were 4.8% (11/228) in the L-AMB and 5.4% (6/111) in the placebo group ( P  =   0.82). The remission-induction phase was a median of 22 days for both groups. Overall mortality was similar between the groups: 7.2% (17/237) for L-AMB and 6.8% (8/118) for placebo ( P  =   1.00). Hypokalaemia and creatinine increase were significantly more frequent with L-AMB. The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, and was not significantly different in patients receiving L-AMB, suggesting that the L-AMB regimen studied is not effective as prophylaxis against IFD. The IFD rate appears higher than previously reported, warranting further investigation. Tolerability of L-AMB was what might be expected. Further studies are needed to determine the optimal antifungal strategy during remission-induction chemotherapy of ALL.
YR 2017
FD 2017
LK https://hdl.handle.net/10668/26496
UL https://hdl.handle.net/10668/26496
LA en
DS RISalud
RD Apr 11, 2025