Actively Recruiting
Phase III Study Comparing GVHD Prevention With ATG-thymoglobulin and ATLG-grafalon in Elderly Patients With AML or MDS Receiving Allogeneic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor Using Fludarabine-treosulfan Reduced Intensity Conditioning
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-27
324
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying elderly patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who need an allogeneic hematopoietic stem cell transplantation (allo-HSCT) using a reduced intensity conditioning (RIC) regimen. The trial compares two different anti-thymocyte globulin (ATG) drugs, ATG-thymoglobulin and ATLG-grafalon, to find the best prevention for graft versus host disease (GVHD) in patients aged 50 to 70 years with matched unrelated donors. This phase III study aims to improve disease control and reduce complications related to GVHD and transplant outcomes in this population. Participants receive conditioning with a fludarabine-treosulfan regimen before transplant. They are randomly assigned to receive either ATLG-grafalon at 10 mg/kg/day intravenously for 3 days or ATG-thymoglobulin at 2.5 mg/kg/day intravenously for 2 days before transplantation. Both drugs are given to prevent GVHD, and the study compares their effects on acute GVHD incidence and other transplant outcomes. The treatment period is followed closely to assess immune recovery and complications. During the study, participants are monitored for acute GVHD up to day 100 after transplant, with additional follow-ups up to 24 months for various health measures, including blood cell recovery, immune cell levels, viral reactivations, relapse rates, survival, and quality of life. Researchers collect blood samples and track clinical events such as infections, organ function, and hospitalization days. Safety and tolerability are evaluated throughout, with long-term assessments to understand the overall impact of the two GVHD prevention strategies on transplant success and patient well-being.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 70 years
- Patients aged 50 to 55 must be unfit for myeloablative conditioning (SORROR score 2)
- Diagnosis of intermediate or high-risk AML in complete cytologic response (CR1 or above) or MDS with IPSS 2 or higher, or with additional risk features
- No available HLA matched related donor
- Identified matched 10/10 HLA unrelated donor
- ECOG performance status of 2 or less
- No severe or uncontrolled infection
- Cardiac ejection fraction of 50% or higher
- Lung diffusion capacity (DLCO) greater than 40%
- Adequate organ function including liver enzymes, bilirubin, and kidney clearance
- Health insurance coverage
- Signed informed consent
- Use of prescribed contraception during the study period
You will not qualify if you...
- Cancer in the last 5 years except skin basal cell carcinoma or in situ cervical carcinoma
- Uncontrolled infection
- HIV, HTLV-1 positive or active hepatitis B or C infection
- Recent live virus vaccination within 2 months before transplantation
- Heart failure NYHA class II or higher or ejection fraction below 50%
- Lung DLCO 40% or less
- Preexisting acute hemorrhagic cystitis
- Renal failure with creatinine clearance below 50 ml/min
- Pregnancy or breastfeeding
- Debilitating medical or psychiatric illness preventing transplantation or protocol understanding
- Under state medical aid or legal protection
- Hypersensitivity to Grafalon or its excipients
- Hypersensitivity to Thymoglobulin or its excipients
- Participation in other interventional clinical trials
- Contraindications to auxiliary drugs planned for the trial (cyclosporine, mycophenolate mofetil, fludarabine, treosulfan)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days before transplantation
Participants receive GVHD prophylaxis treatment with either ATG-thymoglobulin or ATLG-grafalon before undergoing allogeneic stem cell transplantation.
1 visit for treatment administration
Duration - Up to 24 months after transplantation
Participants are monitored for outcomes including GVHD incidence, immune cell levels, chimerism, infections, relapse, survival, and quality of life after transplantation.
Multiple visits including assessments at 1 month, 100 days, 6 months, 12 months, and 24 months post-transplantation
Trial Site Locations
Total: 28 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
CHU Besançon
Besançon, France
Actively Recruiting
4
CHU Bordeaux
Bordeaux, France
Actively Recruiting
5
CHU Brest
Brest, France
Actively Recruiting
6
CHU Caen
Caen, France
Actively Recruiting
7
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
8
Hôpital Henri Mondor AP-HP
Créteil, France
Not Yet Recruiting
9
CHU Grenoble
Grenoble, France
Actively Recruiting
10
CHU Lille
Lille, France
Actively Recruiting
11
CHU Limoges
Limoges, France
Actively Recruiting
12
CHU Lyon Sud
Lyon, France
Actively Recruiting
13
IPC Marseille
Marseille, France
Actively Recruiting
14
CHU Montpellier
Montpellier, France
Actively Recruiting
15
CHRU Nancy
Nancy, France
Actively Recruiting
16
CHU Nantes
Nantes, France
Actively Recruiting
17
CHU Nice
Nice, France
Actively Recruiting
18
Hôpital La Pitié Salpêtrière AP-HP
Paris, France
Actively Recruiting
19
Hôpital Necker AP-HP
Paris, France
Actively Recruiting
20
Hôpital Saint Louis AP-HP
Paris, France
Actively Recruiting
21
Hôpital Saint-Antoine AP-HP
Paris, France
Actively Recruiting
22
CHU Poitiers
Poitiers, France
Actively Recruiting
23
CHU Rennes
Rennes, France
Actively Recruiting
24
CHU Saint Etienne
Saint-Etienne, France
Actively Recruiting
25
CHRU Strasbourg
Strasbourg, France
Actively Recruiting
26
Oncopole Toulouse
Toulouse, France
Actively Recruiting
27
CHRU Tours
Tours, France
Not Yet Recruiting
28
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
R
Régis Peffault de Latour, Pr
J
Jérôme Lambert, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here