Comparing two drugs to prevent graft-versus-host disease after stem cell transplant in older patients

Who can take part

• Age ≥ 50 and ≤ 70 years
• Patient between 50 and 55 years should be unfit for a myeloblative conditioning
• AML requiring allogeneic stem cell transplantation (intermediate or high risk AML) in complete cytologic response (CR1 or above) or MDS requiring allogeneic stem cell transplantation (IPSS≥ 1.5 or IPSS-R > 4.5 or IPSS-R > 3-4.5 with risk features [rapid blast increase, life-threatening neutropenia (<0.3 G/L) or thrombopenia (<30G/L) or high transfusion needs (>2/month for 6 months)]
• Without an HLA matched related donor
• Having an identified matched HLA 10/10 unrelated donor
• With usual criteria for HSCT: a) ECOG performans status ≤ 2 ; b) No severe and uncontrolled infection ; c) Cardiac left ventricular ejection fraction ≥50% ; d) Lung DLCO > 40% ; e) Adequate organ function: ASAT and ALAT ≤ 3N, total bilirubin ≤ 2N, creatinine clearance ≥ 50 mL/min (except if those abnormalities are linked to the hematological disease)
• With health insurance coverage
• Having signed a written informed consent
• Contraception methods must be prescribed during all the duration of the research. NB: The authorized contraceptive methods are: For women of childbearing age and in absence of permanent sterilization: oral, intravaginal or transdermal combined hormonal contraception; oral, injectable or implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormonal releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (only if this is the preferred and usual lifestyle of the participants). For men in absence of permanent sterilization: sexual abstinence, condoms

Who cannot take part

• Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation
• Participation in other clinical trials on medicinal products for human use or being in the exclusion period at the end of a previous study
• Patients with any debilitating medical or psychiatric illness, which would preclude the realization of the SCT or the understanding of the protocol
• For Thymoglobulin : Hypersensitivity to rabbit proteins or to any of the excipients
• Uncontrolled infection
• Seropositivity for HIV or HTLV-1 or active hepatitis B or C
• Heart failure according to NYHA (II or more) or Left ventricular ejection fraction < 50%
• Renal failure with creatinine clearance < 50ml / min
• Carcinoma in the last 5 years (except basal cell carcinoma of the skin or “in situ” carcinoma of the cervix)
• Lung DLCO ≤ 40%
• Preexisting acute hemorrhagic cystitis
• Pregnancy (β-HCG positive) or breast-feeding
• Any contraindications mentioned in the SmPC of all auxiliary medicinal products planned to be used in the trial: cyclosporine, mycophenolate mofetil, fludarabine, treosulfan
• Patient under state medical aid
• Patient under legal protection (protection of the court, or in curatorship or guardianship)
• For Grafalon : Any contraindications mentioned in the SmPC of GRAFALON