Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.