GVHD prevention with Thymoglobulin versus Grafalon in older adults with AML or MDS receiving a 10/10 matched unrelated donor transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III trial enrolls patients aged 50–70 with AML or higher‑risk MDS who are planned for reduced‑intensity allogeneic hematopoietic stem cell transplantation from a 10/10 HLA matched unrelated donor. Participants will be assigned to receive one of two anti‑thymocyte globulin preparations (Thymoglobulin or ATLG/Grafalon) as graft‑versus‑host disease (GVHD) prophylaxis. The study will compare post‑transplant outcomes including rates of acute and chronic GVHD, relapse, survival, and immune recovery. The trial builds on prior work supporting use of ATG to reduce GVHD while monitoring potential effects on graft‑versus‑leukemia activity and overall transplant success.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Besançon
  Besançon, France Recruiting
• CHU Bordeaux
  Bordeaux, France Recruiting
• CHU Brest
  Brest, France Recruiting
• CHU Caen
  Caen, France Recruiting

Study contacts

• Study coordinator: Régis Peffault de Latour, Pr
• Email: regis.peffaultdelatour@aphp.fr
• Phone: +33142385073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.