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Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor

RecruitingPhase 3Ages 50 Years - 70 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Most of the patients requiring an allo-HSCT are above 50 years of age and are transplanted with a reduced intensity conditioning (RIC) regimen. The optimal RIC and Graft Versus Host Disease (GVHD) prophylaxis regimen allowing a good control of the disease while preventing GVHD remains to be determined for elderly patients. A phase III trial comparing the conventional RIC fludarabine-busulfan 2 days to fludarabine-treosulfan demonstrated an advantage for the flu-treosulfan arm in terms of event free survival (EFS), that should therefore be considered as the new standard of RIC regimen for AML and MDS. GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia (GVL)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 50 and ≤ 70 years 2. Patient between 50 and 55 years should be unfit for a myeloblative conditioning (SORROR score ≥2) 3. 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 \[rapide blast increase, life-threatening neutropenia (\<0.3 G/L) or thrombopenia (\<30G/L) or high transfusion needs (\>2/month for 6 months)\] 4. Without an HLA matched related donor 5. Having an identified matched HLA 10/10 unrelated donor 6. With usual criteria for HSCT: 1. ECOG performans status ≤ 2 2. No severe and uncontrolled infection 3. Cardiac left ventricular ejection fraction ≥50% 4. Lung DLCO \> 40% 5. 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) 7. With health insurance coverage 8. Having signed a written informed consent 9. 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 transdermal progestogen-only hormonal contraception, intrauterine hormonal releasing system (IUS), sexual abstinence (only if this the preferred and usual lifestyle of the participants). * For man in absence of permanent sterilization: sexual abstinence, condoms Exclusion Criteria: 1. Cancer in the last 5 years (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) 2. Uncontrolled infection 3. Seropositivity for HIV or HTLV-1 or active hepatitis B or C 4. Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation 5. Heart failure according to NYHA (II or more) or Left ventricular ejection fraction \< 50%. 6. Lung DLCO ≤ 40% 7. Preexisting acute hemorrhagic cystitis 8. Renal failure with creatinine clearance \< 50ml / min 9. Pregnancy (β-HCG positive) or breast-feeding 10. Patients with any debilitating medical or psychiatric illness, which would preclude the realization of the SCT or the understanding of the protocol 11. Patient under state medical aid 12. Patient under legal protection (protection of the court, or in curatorship or guardianship). 13. For Grafalon: Hypersensitivity to the active substance or to any of the excipients 14. For Thymoglobulin: Hypersensitivity to rabbit proteins or to any of the excipients 15. Participation in other interventional clinical trials 16. Any contraindication mentioned in the SmPC of all auxiliary medicinal products planned to be used in the trial: cyclosporine, mycophenolate mofetil, fludarabine, treosulfan
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What it tests

  • Grafalon
  • Thymoglobulin
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Where

28 sites
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU Brest
Brest, France
CHU Caen
Caen, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Henri Mondor AP-HP
Créteil, France

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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