Acute Myeloid Leukemia (AML) MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: BUSILVEX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Busulfan
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number: .8-
Trade Name: FLU
Sponsors
GITMO (GRUPPO ITALIANO DI MIDOLLLO OSSEO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients  Age  40 and  65 years  Diagnosis of AML (FAB or WHO classification) in Complete Remission (CR)  Availability of an HLA compatible sibling or unrelated donor  Performance status : ECOG=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients  AML patients in 1st CR with: o t(15;17) or PML/RARα positive APL o t(8;21)(q22;q22) with WBC count at diagnosis less than 20 x 109/L without additional adverse cytogenetic abnormalities. o 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 HIV serology  Any major organ dysfunction  Pulmonary dysfunction (FEV1 1.5 mg% or serum transaminases >2x UNL)  Chronic active hepatitis or cirrhosis  Cardiac dysfunction (LVEF 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  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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: Assessment in the two arms of the safety and efficacy profile defined as: early and/or late graft rejection, hematopoietic recovery, chimerism, toxicity and incidence of VOD, incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD), cumulative incidence of TRM, relapse, event-free (EFS) and overall survival (OS);Primary end point(s): Cumulative incidence of TRM (defined as non-relapse mortality) at 1 year post transplant in each arm | — |
Countries
Israel, Italy
Contacts
Public ContactSegreteria Organizzativa
Consorzio Mario Negri Sud
Outcome results
None listed