Status:
COMPLETED
Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML
Lead Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief 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 allogenei...
Detailed Description
Hematopoietic stem-cell transplantation (HSCT) is a potentially curative treatment modality for patients with Acute Myelogenous Leukemia (AML). An effective conditioning regimen is based on the assoc...
Eligibility Criteria
Inclusion
- Patients
- Age more than 40 and less than 65 years
- Diagnosis of AML (FAB or WHO classification) in Complete Remission (CR)
- Availability of an HLA compatible sibling or unrelated donor
- Performance status : Eastern Cooperative Oncology Group (ECOG)\<3
- Written and signed informed consent
- Central Venous access (Central KT) secured through an indwelling catheter.
- Life expectancy not severely limited by concomitant illness. Donors
- Age between 18 years and 65 years inclusive.
- Availability of an HLA-identical sibling donor (MRD) or HLA-compatible unrelated donor (MUD). Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA- A, B, and C) and class II (DRB1). In case, no class I and class II completely identical donor (8 out of 8 gene loci) can be identified, one antigen/allele disparity (class I) or one allele disparity (class II, DRB1) between patient and donor are acceptable. In any cases the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry.
Exclusion
- Patients
- AML patients in 1st CR with:
- t(15;17) or promyelocytic leukemia/retinoic acid receptor gene translocation, PML/RARα positive APL
- t(8;21)(q22;q22) with white blood cells (WBC) 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 HIV serology
- Any major organ dysfunction
- Pulmonary dysfunction (Fraction Ejection Volume, FEV1 \<40%, Diffusing Capacity of Lung for carbon monoxide, DLCO \<50%,)
- Hepatic dysfunction (Serum bilirubin \>1.5 mg% or serum transaminases \>2x UNL)
- Chronic active hepatitis or cirrhosis
- Cardiac dysfunction (LVEF \<40)
- Chronic renal insufficiency (Serum creatinine \>1.5 mg/dl or creatinine clearance \<=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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01191957
Start Date
January 1 2008
End Date
October 1 2014
Last Update
March 10 2023
Active Locations (26)
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1
Chaim Sheba Medical Center
Tel Litwinsky, Israel
2
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
3
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, Italy
4
Clinica di Ematologia - Ospedali Riuniti di Ancona
Ancona, Italy