Study comparing thymoglobulin to grafalon, two treatments used to prevent graft versus host disease in elderly patients with acute myeloid leukemia or myelodysplastic syndrome and receiving an allogeneic stem cell transplantation with an unrelated matched donor after a reduced intensity conditioning regimen

Trial details

Who runs it

Assistance Publique Hopitaux De Paris

Trial code

EU 2023-504555-27-00

Record updated

2026. július 15.

Original description

To compare the incidence of grade II-IV acute GVHD at day 100 post-transplantation in MDS or AML patients transplanted with a 10/10 matched unrelated donor (MUD) following a reduced intensity conditioning with fludarabine-treosulfan between patients receiving a GVHD prophylaxis with ATG-thymoglobulin versus ATLG-grafalonRead full original descriptionShow less

Phase III study comparing GVHD prophylaxis with ATG-thymoglobulin to ATLG-grafalon in elderly patients with acute myeloid leukemia or myelodysplastic syndrome and receiving an allogeneic hematopoietic stem cell transplantation with a 10/10 HLA matched unrelated donor following a reduced intensity conditioning regimen by fludarabine-treosulfan (OPTISAGE)

To compare the incidence of grade II-IV acute GVHD at day 100 post-transplantation in MDS or AML patients transplanted with a 10/10 matched unrelated donor (MUD) following a reduced intensity conditioning with fludarabine-treosulfan between patients receiving a GVHD prophylaxis with ATG-thymoglobulin versus ATLG-grafalon

Inclusion: 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.

Exclusion: 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.

EU CTIS 2023-504555-27-00