Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis (AMBINEB)

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00391014
First received: October 20, 2006
Last updated: May 11, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukemia
Allogeneic Haematopoietic Progenitor Cell Transplant
Drug: liposomal Amphotericine B
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy and safety prophylaxis against IPA in LMA patients. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2006
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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.

Drug: liposomal Amphotericine B

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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391014

Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario la Fe
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Principal Investigator: Ruiz Isabel, Dr Hospital Universitari Vall d'Hebron
Principal Investigator: Rovira Montserrat, Dr Hospital Clinic of Barcelona
  More Information

Additional Information:
Publications:
Denning DW. Invasive aspergillosis. Clinical Infectious Diseases. 1998;26:781-803.
Yeldandi V, Laghi F, McCabe MA, Larson R, O'Keefe P, Husain A et al. Aspergillus and lung transplantation. J Heart Lung Transplant. 1995;14:883-90.

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00391014     History of Changes
Other Study ID Numbers: 2005-000703-34, AMBINEB
Study First Received: October 20, 2006
Last Updated: May 11, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute myeloid Leukemia
Allogeneic haematopoietic progenitor cell transplant
Acute Invasive Aspergillosis

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Neoplasms by Histologic Type
Neoplasms
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 30, 2014