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

May 11, 2009 updated by: PETHEMA Foundation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Valencia, Spain
        • Hospital Universitario La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy and safety prophylaxis against IPA in LMA patients.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Principal Investigator: Ruiz Isabel, Dr, Hospital Vall d'Hebron
  • Principal Investigator: Rovira Montserrat, Dr, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

October 20, 2006

First Submitted That Met QC Criteria

October 20, 2006

First Posted (ESTIMATE)

October 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-000703-34
  • AMBINEB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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