Acute Myeloid Leukemia Clinical Trial
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)
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
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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