Pilot study on safety of four weekly administrations of 7 mg/kg of liposomal amphotericin B (AmBisome®) in antifungal primary prophylaxis treatment ofelderly patients with acute lymphoblastic leukemia undergoing induction chemotherapy within the GMALL-Elderly protocol. - ProphyA

• Conditions: Antifungal prophylaxis; MedDRA version: 8.1Level: PTClassification code 10049085Term: Antifungal prophylaxis

• Registration Number: EUCTR2005-004495-21-DE
• Lead Sponsor: Gilead Sciences GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified