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
Inclusion Criteria14
- Patients
- Age = between 40 and 55
- Diagnosis of acute myeloid Leukimia (AML) (Francese-Americana-Britannica or Word Healt Organization classification) in Complete Remission (CR)
- Availability of an HLA compatible sibling or unrelated donor
- Performance status : Eastern Cooperative Oncology Group code(ECOG)<3
- Written and signed informed consent
- Central Venous access secured through an indwelling catheter.
- Life expectancy not severely limited by concomitant illness.
- Donors
- Age between 18 years and 65 years inclusive.
- Donors are assessed by HLA-A, -B, -C, -DRB1, DQB1 high-resolution typing and can be either
- HLA identical sibling or HLA phenotypically identical family donor
- or
- HLA-matched unrelated with one allele mismatched (Class I or II).
Exclusion Criteria26
- Patients
- AML patients in 1st CR with:
- t(15;17) or mutation of gene called PML/RARa positive Acute Promyelocytic Leukimia
- t(8;21)(q22;q22) with White Blood Cell count at diagnosis less than 20 x 109/L without
- additional adverse cytogenetic abnormalities.
- inv(16) or t(16;16)(p13;q22) without additional adverse cytogenetic abnormalities.
- Previous allogeneic transplantation
- Poorly controlled arterial hypertension with blood pressure above 150/90 on standard
- medication
- Acute Myocardial Infarction (AMI) within the last 12 months
- Positive pregnancy test (in women not in menopause)
- Positive Human Immunodeficiency Virus (HIV) serology
- Any major organ dysfunction
- Pulmonary dysfunction (Forced Expiratory Volume in One Second (FEV1) <40%, Diffusion Capacity Lung Oxigen (DLCO test) <50%,)
- Hepatic dysfunction (Serum bilirubin >1.5 mg% or serum transaminases >2)
- Chronic active hepatitis or cirrhosis
- Cardiac dysfunction (left ventricular ejection fraction (LVEF) <40)
- Chronic renal insufficiency (Serum creatinine >1.5 mg/dl or creatinine cleareance <=50 ml/min)
- Invasive fungal infection still evolutive at the time of registration
- Central nervous system involvement
- Uncontrolled oral/dental infections
- Abnormal dental evaluation
- Patient has another progressive malignant disease or a history of other malignancies within 2
- years prior to study entry
- Severe psychiatric illness or any disorder that compromises ability to give truly informed
- consent for participation in this study
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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