Acute Myeloid Leukemia Clinical Trial
— AMBINEBOfficial 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)
Verified date | May 2009 |
Source | PETHEMA Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
PETHEMA Foundation |
Spain,
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Myers SE, Devine SM, Topper RL, Ondrey M, Chandler C, O'Toole K, Williams SF, Larson RA, Geller RB. A pilot study of prophylactic aerosolized amphotericin B in patients at risk for prolonged neutropenia. Leuk Lymphoma. 1992 Oct;8(3):229-33. — View Citation
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Schmitt HJ, Bernard EM, Häuser M, Armstrong D. Aerosol amphotericin B is effective for prophylaxis and therapy in a rat model of pulmonary aspergillosis. Antimicrob Agents Chemother. 1988 Nov;32(11):1676-9. — View Citation
Schwartz S, Behre G, Heinemann V, Wandt H, Schilling E, Arning M, Trittin A, Kern WV, Boenisch O, Bosse D, Lenz K, Ludwig WD, Hiddemann W, Siegert W, Beyer J. Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial. Blood. 1999 Jun 1;93(11):3654-61. — View Citation
Siwek GT, Dodgson KJ, de Magalhaes-Silverman M, Bartelt LA, Kilborn SB, Hoth PL, Diekema DJ, Pfaller MA. Invasive zygomycosis in hematopoietic stem cell transplant recipients receiving voriconazole prophylaxis. Clin Infect Dis. 2004 Aug 15;39(4):584-7. Epub 2004 Jul 30. — View Citation
Thomas DA, Myers MA, Wichert B, Schreier H, Gonzalez-Rothi RJ. Acute effects of liposome aerosol inhalation on pulmonary function in healthy human volunteers. Chest. 1991 May;99(5):1268-70. — View Citation
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy and safety prophylaxis against IPA in LMA patients. | 1 year | Yes |
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