Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391014
Status:
COMPLETED
Last Update Posted:
2009-05-12
First Post:
2006-10-20
Brief Title:
Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMBINEB
Brief Summary:
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
Detailed Description:
The invasive fungal infection IFI is the most common cause of mortality related to autologous stem cell transplant Taking into account that Saprophytic Aspergillus is usually acquired by inhalation to protect the bronchial tree just before the tissue invasion is quite attractive In haematologic patients as well as those ones subjected to an Allogeneic haematopoietic progenitor cell transplant there is another group of patients at high risk of Invasive Pulmonary Aspergillosis IPA These are those patients with acute myeloid leucemia AML submitted to induction intensification or consolidation polychemotherapy The IPA incidence rate in these patients whenever during their evolution reaches 18-20 with usual treatments Furthermore unlike allogeneic haematopoietic progenitor cell transplant patients neutropenia was the only IPA risk factor Nowadays pharmacologic prophylaxis against IPA in patients with allogeneic haematopoietic progenitor cell transplant and patients affected by AML in induction or intensification therapy is far from being optimal because of problems related to tolerance and drug interactions
The Nebulized Liposomal Amphotericin B Ambisome prophylaxis against IPA has shown good tolerance safety and efficacy in lung transplant recipients
Extrapolating the results obtained in lung transplant recipients we get the conclusion that it would be essential to study safety and tolerance of nebulized AMBISOME in the group of patients with different peculiarities mucositis secondary to chemotherapy and high incidence of IPA in order to reach the goal of evaluate its efficacy as prophylaxis against IPA in this kind of patients
The Nebulized Liposomal Amphotericin B Ambisome prophylaxis against IPA has shown good tolerance safety and efficacy in lung transplant recipients
Extrapolating the results obtained in lung transplant recipients we get the conclusion that it would be essential to study safety and tolerance of nebulized AMBISOME in the group of patients with different peculiarities mucositis secondary to chemotherapy and high incidence of IPA in order to reach the goal of evaluate its efficacy as prophylaxis against IPA in this kind of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AMBINEB | None | None | None |