Clinical trial · Interventional
Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis
AMBINEB: Clinical Trial to Evaluate Tolerance and Safety of Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis in Patients With Acute Myeloid Leukemia and Allogeneic Haematopoietic Progenitor Cell Transplant (Alo-HPCT)
NCT00391014CI-TRIAL-00002297AMBINEBcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial is planned as a multicentric, national, phase II, open-label trial to evaluate safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during the induction therapy ,intensification, plus Allogeneic Haematopoietic Progenitor Cell transplant in due course, as well for patients diagnosed of several malignant haematologic diseases and treated with Allogeneic Haematopoietic Progenitor Cell Transplant
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Allogeneic Haematopoietic Progenitor Cell Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal Amphotericine B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- AML patients in induction chemotherapy treatment will received prophylaxis with nebulized liposomal amphotericin B (24 mg/week). It will be maintained during the intensification chemotherapy and in periods between cycles. If patient required ALO-TPH, the prophylaxis should be followed.
- interventionNames
- Drug: liposomal Amphotericine B
Primary outcomes (1)
- measure
- Efficacy and safety prophylaxis against IPA in LMA patients.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. * Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant. * The patient is \>18 years old. Exclusion Criteria: * Patient with prior Invasive Pulmonary Aspergillosis (IPA) history. * History of allergy or hypersensitivity to Amphotericin B. * Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding. * Pregnancy or breastfeeding. * Patient has received other investigational drug or non traded product within 30 days before trial beginning. * Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason. * Patient had major surgery within 4 weeks before enrollment.
References
Publications (24)
- BACKGROUNDDenning DW. Invasive aspergillosis. Clin Infect Dis. 1998 Apr;26(4):781-803; quiz 804-5. doi: 10.1086/513943. No abstract available. PMID 9564455
- BACKGROUNDMarr KA, Carter RA, Boeckh M, Martin P, Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002 Dec 15;100(13):4358-66. doi: 10.1182/blood-2002-05-1496. Epub 2002 Aug 22. PMID 12393425
- BACKGROUNDWinston DJ, Maziarz RT, Chandrasekar PH, Lazarus HM, Goldman M, Blumer JL, Leitz GJ, Territo MC. Intravenous and oral itraconazole versus intravenous and oral fluconazole for long-term antifungal prophylaxis in allogeneic hematopoietic stem-cell transplant recipients. A multicenter, randomized trial. Ann Intern Med. 2003 May 6;138(9):705-13. doi: 10.7326/0003-4819-138-9-200305060-00006. PMID 12729424
- BACKGROUNDSiwek GT, Dodgson KJ, de Magalhaes-Silverman M, Bartelt LA, Kilborn SB, Hoth PL, Diekema DJ, Pfaller MA. Invasive zygomycosis in hematopoietic stem cell transplant recipients receiving voriconazole prophylaxis. Clin Infect Dis. 2004 Aug 15;39(4):584-7. doi: 10.1086/422723. Epub 2004 Jul 30. PMID 15356827
- BACKGROUNDKramer MR, Denning DW, Marshall SE, Ross DJ, Berry G, Lewiston NJ, Stevens DA, Theodore J. Ulcerative tracheobronchitis after lung transplantation. A new form of invasive aspergillosis. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):552-6. doi: 10.1164/ajrccm/144.3_Pt_1.552. PMID 1654038
- BACKGROUNDYeldandi V, Laghi F, McCabe MA, Larson R, O'Keefe P, Husain A, Montoya A, Garrity ER Jr. Aspergillus and lung transplantation. J Heart Lung Transplant. 1995 Sep-Oct;14(5):883-90. PMID 8800724
- BACKGROUNDWestney GE, Kesten S, De Hoyos A, Chapparro C, Winton T, Maurer JR. Aspergillus infection in single and double lung transplant recipients. Transplantation. 1996 Mar 27;61(6):915-9. doi: 10.1097/00007890-199603270-00013.