RecruitingPhase 3ACTRN12609000997257

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.


Sponsor

GITMO (Gruppo Italiano Trapianto Midollo Osseo)

Enrollment

240 participants

Start Date

Jan 3, 2008

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of chemotherapy preparation (conditioning) given before a stem cell transplant in patients aged 40 to 55 with acute myeloid leukaemia (a type of blood cancer) that is currently in remission. One preparation uses busulfan plus fludarabine (BuFlu), which is newer and thought to be less toxic. The other uses the older standard of busulfan plus cyclophosphamide (BuCy2). Researchers want to find out which combination leads to fewer deaths related to the transplant procedure itself. You may be eligible if: - You are between 40 and 55 years old - You have been diagnosed with acute myeloid leukaemia (AML) that is currently in complete remission - A matched stem cell donor is available (sibling or unrelated) - Your performance status is reasonable (ECOG score below 3) - Your heart, lungs, liver, and kidneys are functioning well enough You may NOT be eligible if: - You have a previous history of stem cell transplantation - You have poorly controlled high blood pressure - You have had a heart attack in the past 12 months - You are pregnant - You are HIV positive or have active hepatitis - You have significant organ dysfunction (heart, lungs, liver, or kidneys) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 (H

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)

Italy

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