Randomized Study Comparing Intravenous Busulfan (i.v. Bu; Busilvex [Registered Trademark]) plus Fludarabine (Buflu) Versus Intravenous Busulfan Plus Cyclophosphamide (Bucy2) As Conditioning Regimens Prior To Allogeneic Hematopoietic Stem Cell Transplantation (ALLOHSCT) In Patients (from 40 to 55 years) With Acute Myeloid Leukemia (AML) In Complete Remission (CR).
Busilvex plus Fludarabine Vs Busilvex plus Cyclophosphamide prior allogeneic transplantation in Acure Myeloid Leukimia (AML) to evaluate the transplant-related mortality.
GITMO (Gruppo Italiano Trapianto Midollo Osseo)
240 participants
Jan 3, 2008
Interventional
Conditions
Summary
The purpose of this prospective phase III, open-label, randomized multi-center study is to evaluate one year transplant-related mortality (TRM) of AML patients undergoing allogeneic hematopoietic stem cell transplantation after a reduced toxicity conditioning regimen (I.V.BuFlu) as compared to the conventional I.V. BuCy2 program
Eligibility
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Interventions
The purpose of this prospective phase III, open-label, randomized multi-center study is to evaluate whether AML elderly patients in CR undergoing allogeneic hematopoietic stem cell transplantation (HSCT) after a reduce toxicity conditioning regimen I.V. BuFlu [I.V. Bu (Busilvex), 12.8 mg/kg four times a day, for four days, plus Fludarabine, 40 mg/m² i.v. one time a day for four days] as compared to the conventional I.V. BuCy2 program [I.V. Bu (Busilvex), 12.8 mg/kg, four times a day, for four days, followed by Cyclophosphamide, 60 mg/kg iv one time a day for two days] will experience: 1. A lower transplant-related mortality (TRM) at 1 year after allogenic stem cell transplantation (HSCT) 2. A similar anti-leukemic activity and a similar or better safety profile
Locations(1)
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ACTRN12609000997257