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

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 Following a Reduced Intensity Conditioning Regimen by Fludarabine-treosulfan

PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT06083129

This trial tests whether Thymoglobulin or Grafalon better prevents graft-versus-host disease in people aged 50–70 with AML or MDS who are receiving a 10/10 HLA matched unrelated donor stem cell transplant.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment324 (estimated)
Ages50 Years to 70 Years
SexAll
SponsorAssistance Publique - Hôpitaux de Paris (other)
Drugs / interventionsfludarabine
Locations28 sites (Amiens and 27 other locations)
Trial IDNCT06083129 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–70 with intermediate or high‑risk AML in remission or higher‑risk MDS who lack a matched related donor, have an identified 10/10 matched unrelated donor, and meet standard transplant fitness criteria (ECOG ≤2 and adequate organ function).

Not a fit: Patients without a 10/10 matched unrelated donor, those younger than 50 or older than 70 outside the specified fitness exceptions, or those with uncontrolled infections or inadequate organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify which ATG product better lowers GVHD risk while maintaining disease control and improving survival in older transplant recipients.

How similar studies have performed: Previous studies have shown that ATG reduces GVHD risk and that reduced‑intensity regimens like fludarabine‑treosulfan can improve outcomes, but direct head‑to‑head comparisons between Thymoglobulin and Grafalon in this elderly transplant population are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Amiens and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: GVHD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.