None listed
Conditions
Brief 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
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
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
Sponsors
GITMO (Gruppo Italiano Trapianto Midollo Osseo)
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed