Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML

• Status: Completed
• Trial end date: 2014-10-01

Summary

The purpose of this prospective phase III, open-label, randomized multicenter study is to evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR) undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity conditioning regimen (I.V. BuFlu) as compared to the conventional I.V.

BuCy2 program will experience:

1. A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells Transplant (HSCT)

2. A similar anti-leukemic activity and a similar or better safety profile, in terms of:

• Early and/or late graft rejection

• Hematopoietic and immunologic recovery

• Chimerism

• Toxicity and incidence of Veno-occlusive Disease (VOD)

• Acute (aGvHD) and chronic graft-versus-host disease (cGvHD)

• Cumulative incidence of TRM at +100 days and 2 years after transplant

• Cumulative incidence of relapse by 1 and 2 years after transplant

• Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant

• Phase: Phase 3

Details

• Lead Sponsor: Gruppo Italiano Trapianto di Midollo Osseo
• Treatments: Busulfan; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine