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Which drug better prevents transplant complications in older leukemia patients?

NCT ID NCT06083129

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests two drugs, Thymoglobulin and Grafalon, to see which one better prevents graft-versus-host disease (GVHD) in patients aged 50-70 with acute myeloid leukemia or myelodysplastic syndrome. All participants receive a stem cell transplant from a matched unrelated donor. The study aims to reduce GVHD severity and improve recovery without increasing cancer relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thymoglobulin and Grafalon (anti-thymocyte globulins)
What this could lead to
If successful, this study could identify the better drug to prevent graft-versus-host disease, improving survival and quality of life for older leukemia patients after transplant.
What could go wrong
This is a head-to-head comparison of two existing drugs, so no breakthrough cure is expected. Results may show only a modest benefit, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia graft versus host disease myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GVHD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHRU Nancy

    RECRUITING

    Nancy, France

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, France

  • CHRU Tours

    NOT_YET_RECRUITING

    Tours, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU Brest

    RECRUITING

    Brest, France

  • CHU Caen

    RECRUITING

    Caen, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Lyon Sud

    RECRUITING

    Lyon, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • CHU Nantes

    RECRUITING

    Nantes, France

  • CHU Nice

    RECRUITING

    Nice, France

  • CHU Poitiers

    RECRUITING

    Poitiers, France

  • CHU Rennes

    RECRUITING

    Rennes, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • Hôpital Henri Mondor AP-HP

    NOT_YET_RECRUITING

    Créteil, France

  • Hôpital La Pitié Salpêtrière AP-HP

    RECRUITING

    Paris, France

  • Hôpital Necker AP-HP

    RECRUITING

    Paris, France

  • Hôpital Saint Louis AP-HP

    RECRUITING

    Paris, France

  • Hôpital Saint-Antoine AP-HP

    RECRUITING

    Paris, France

  • IPC Marseille

    RECRUITING

    Marseille, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Oncopole Toulouse

    RECRUITING

    Toulouse, France

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