LIPOSOMAL AMPHOTERICIN B (AMBISOME) 10 mg/kg once a week for 10 weeks as maintenance antifungal therapy for Proven/Probable Invasive Fungal Infection in hematologic patients with Acute Myeloid Leukaemia and/or in Allogeneic Hematopoietic Stem Cell Transplant recipients.

LIPOSOMAL AMPHOTERICIN B (AMBISOME) 10 mg/kg once a week for 10 weeks as maintenance antifungal therapy for Proven/Probable Invasive Fungal Infection in hematologic patients with Acute Myeloid Leukaemia and/or in Allogeneic Hematopoietic Stem Cell Transplant recipients. - AMBIHOW

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001845-34-IT

Enrollment

Registered

2012-03-02

Start date

2011-09-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proven/Probable Invasive Fungal Infection in hematologic patients with Acute Myeloid Leukaemia and/or in Allogeneic Hematopoietic Stem Cell Transplant recipients. MedDRA version: 14.1 Level: PT Classification code 10061730 Term: Bone marrow transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and po

Interventions

Trade Name: AMBISOME*INFUS 10FL LIOF 50MG Pharmaceutical Form: Powder for infusion INN or Proposed INN: AMPHOTERICINE B, LIPOSOME CAS Number: 8000078822 Current Sponsor code: NA Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion ? Patients with diagnosis of AML in treatment with high dose chemotherapy or undergoing Allogeneic-HSCT, with a life expectancy superior to 3 months ? Age superior or egual to 18 years ? Probable or Proven IA according with EORTC criteria21, treated with L-AMB 3 mg/kg/die for 14 days ? Favorable overall clinical response reached, defined by the criteria described in Table 2; also, patients with stable response after 14 days of treatment will be included Note: response assessment is usually made later than 14 days from start of treatment, i.e. at the time of potential enrollment in the present trial. We therefore think that patient stable at this time-point do not represent (yet) a clinical failure and therefore can be included in the study. ? Creatinine clearance superior to 50 ml/min ? Serum potassium superior to 3.5 mg/mL ? AST / ALT inferor to 5 times upper limit of normal ? Willingness to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27

Exclusion criteria

Exclusion criteria: ? Diagnosis of IFI other than IA ? Life expectancy <30 days ? Participation in other experimental studies at the time of consent ? Ongoing pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to assess the efficacy of 10 administrations of L-AmB 10 mg/kg once a week as maintenance antifungal therapy after 14 days of standard therapy with L-AmB 3 mg/kg once a day in hematologic patients in treatment for Acute Myeloid Leukemia and Allogeneic-HSCT recipients with a diagnosis of Probable/Proven IFI with complete, partial response or stable disease, in terms of complete partial or response at 10 weeks from start of maintenance therapy (i.e. overall treatment duration 12 weeks).;Secondary Objective: •To estimate FFS and OS at 10 and 22 weeks (i.e. 12 and 24 weeks from treatment initiation); •To estimate the proportion of patients with adverse event, globally and for each adverse event; •To calculate the Daily Dose Dispensed (DDD) for L-AmB in this therapeutic regimen; •To calculate hospital stay duration;Primary end point(s): Efficacy of 10 administrations of L-AmB 10 mg/kg once a week as maintenance antifungal therapy after 14 days of standard therapy with L-AmB 3 mg/kg once a day in hematologic patients in treatment for Acute Myeloid Leukemia and Allogeneic-HSCT recipients with a diagnosis of Probable/Proven IFI with complete, partial response or stable disease, in terms of complete partial or response at 10 weeks from start of maintenance therapy;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: The main objective of the study is to assess the efficacy of 10 administrations of L-AmB 10 mg/kg once a week as maintenance antifungal therapy after 14 days of standard therapy with L-AmB 3 mg/kg once a day in hematologic patients in treatment for Acute Myeloid Leukemia and Allogeneic-HSCT recipients with a diagnosis of Probable/Proven IFI with complete, partial response or stable disease, in terms of complete partial or response at 10 weeks from start of maintenance therapy (i.e. overall treatment duration 12 weeks).;Secondary Objective: •To estimate FFS and OS at 10 and 22 weeks (i.e. 12 and 24 weeks from treatment initiation); •To estimate the proportion of patients with adverse event, globally and for each adverse event; •To calculate the Daily Dose Dispensed (DDD) for L-AmB in this therapeutic regimen; •To calculate hospital stay duration;Primary end point(s): Efficacy of 10 administrations of L-AmB 10 mg/kg once a week as maintenance antifungal therapy after 14 days of standard therapy with L-AmB 3 mg/kg once a day in hematologic patients in treatment for Acute Myeloid Leukemia and Allogeneic-HSCT recipients with a diagnosis of Probable/Proven IFI with complete, partial response or stable disease, in terms of complete partial or response at 10 weeks from start of maintenance therapy;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): • To estimate FFS and OS at 10 and 22 weeks (i.e. 12 and 24 weeks from treatment initiation); • To estimate the proportion of patients with adverse event, globally and for each adverse event; • To calculate the Daily Dose Dispensed (DDD) for L-AmB in this therapeutic regimen; • To calculate hospital stay duration;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Secondary end point(s): • To estimate FFS and OS at 10 and 22 weeks (i.e. 12 and 24 weeks from treatment initiation); • To estimate the proportion of patients with adverse event, globally and for each adverse event; • To calculate the Daily Dose Dispensed (DDD) for L-AmB in this therapeutic regimen; • To calculate hospital stay duration;Timepoint(s) of evaluation of this end point: 24 weeks

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Countries

Italy

Contacts

Public ContactU.O. Malattie Infettive Prof. Viale

AOU di Bologna, Policlinico S.Orsola-Malpighi

pierluigi.viale@unibo.it051/6363353

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026