Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis

Condition(s) targeted: Acute Myeloid Leukemia; Allogeneic Haematopoietic Progenitor Cell Transplant

Intervention: liposomal Amphotericine B (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Ruiz Isabel, Dr, Principal Investigator, Affiliation: Hospital Universitari Vall d'Hebron
Rovira Montserrat, Dr, Principal Investigator, Affiliation: Hospital Clínic Barcelona

Overall contact:
Ruiz Camps Isabel, Dr, Phone: 34-93 274 60 90, Email: iruiz@vhebron.net

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

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)

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Efficacy and safety prophylaxis against IPA in LMA patients.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Ruiz Camps Isabel, Dr, Phone: 34-93 274 60 90, Email: iruiz@vhebron.net

Hospital Universitario de Salamanca, Salamanca, Spain; Recruiting
Vazquez Lourdes, Dr, Principal Investigator

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Recruiting
Martino Rodrigo, Dr
Martino Rodrigo, Dr, Principal Investigator

Hospital Universitario de la Princesa, Madrid, Spain; Recruiting
De la Cámara Rafael, Dr
de la Cámara Rafael, Dr, Principal Investigator

Hospital Universitario la Fe, Valencia, Spain; Recruiting
Sanz Miguel Angel
Sanz Miguel Angel, Dr, Principal Investigator

Pethema Foundation web

Spanish association of Haematology

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Starting date: January 2006
Ending date: February 2009
Last updated: November 17, 2008