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New stem cell protocol offers hope for older adults with aplastic anemia

NCT ID NCT06646497

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a stem cell transplant method for adults aged 40 to 60 with severe aplastic anemia that has not improved or has returned after standard drug therapy. The approach uses a special drug after transplant to lower the risk of graft-versus-host disease, a common and serious complication. About 52 participants will receive this optimized transplant to see if it improves survival without severe side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 people

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

Started

Jan 2025

Expected to finish

Jan 2030

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

40 to 60 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: * Aged from 40 to 60 years old * Suffering from acquired refractory severe idiopathic aplastic anemia after at least 6 months treatment with anti-thymocyte globulin, cyclosporine with Eltrombopag or in relapse * Allograft validated in the National Multidisciplinary expertise meetings of the French reference centre for aplastic anemia * With an available geno-identical donor or 10/10 matched donor or haploidentical donor * With the absence of donor specific antibody detected in the patient with a MFI \< 1500 (antibodies to the distinct haplotype between donor and recipient) * Usual criteria for HSCT: * ECOG ≤ 2 * No severe and uncontrolled infection * Cardiac function compatible with high dose of cyclophosphamide * With an adequate organ function ASAT and ALAT ≤ 3N, conjugated bilirubin ≤ 2N (or total bilirubin ≤ 2N if not available), clearance creatinine ≥ 50ml / min * With health insurance coverage * Women of childbearing potential and men must use contraceptive methods during their participation to the research and for 12 months and 6 months after the last dose of cyclophosphamide, respectively. * Having signed a written informed consent 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 (need to be evaluated in relation to the duration of clinical trial and the preferred and usual lifestyle of the participants). For men in absence of permanent sterilization: sexual abstinence, condoms. Individuals must meet all of the inclusion criteria as verified at the screening / inclusion visit to be eligible to participate at the study. Exclusion Criteria: Patients: * With morphologic evidence of clonal evolution (patients with isolated bone marrow cytogenetic abnormalities are also eligible excepted chromosome 7 abnormalities and complex karyotype). * With seropositivity for HIV or HTLV-1-2 or active hepatitis B or C and associated hepatic cytolysis * Cancer in the last 5 years (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) * Pregnant (βHCG positive) or breast-feeding * Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation and during the research * With uncontrolled coronary insufficiency, recent myocardial infarction \< 6-month, current manifestations of heart failure according to NYHA (II or more), ventricular ejection fraction \<50% * With renal failure with creatinine clearance \<50ml /min * Any contraindication mentioned in the SmPC and the Investigator's brochure of all medicinal products planned to be used in the trial including conditioning regimen, GVHD prophylaxis, prevention of EBV reactivation, infection prophylaxis * Known allergy or intolerance to all medicinal products and/or excipients planned to be used in the trial including conditioning regimen, GVHD prophylaxis, prevention of EBV reactivation, infection prophylaxis, according to Investigator's brochure and SmPC. * Who have any debilitating medical or psychiatric illness, which precludes understanding the inform consent as well as optimal treatment and follow-up * Under legal protection (tutorship or curatorship) * Under state medical aid * Participation to another interventional trial on a medicinal product or cell therapy Individuals meeting any of the exclusion criteria as verified at the screening / inclusion visit will be ineligible to participate at the study.

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Conditions

The condition(s) this trial relates to.

aplastic anemia idiopathic aplastic anemia

As listed by the trial registrant

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

Aplastic anemia

How to take part

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

  1. The places running it

    26 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

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU Caen

    NOT_YET_RECRUITING

    Caen, France

  • CHU Grenoble Alpes

    RECRUITING

    Grenoble, France

  • CHU Lille

    NOT_YET_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

    NOT_YET_RECRUITING

    Rennes, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • CHU Strasbourg

    RECRUITING

    Strasbourg, France

  • CHU Toulouse

    RECRUITING

    Toulouse, France

  • HNIA Percy

    RECRUITING

    Clamart, France

  • Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, France

  • Hopital Necker - APHP

    RECRUITING

    Paris, France

  • Hôpital Henri Mondor AP-HP

    NOT_YET_RECRUITING

    Créteil, France

  • Hôpital La Pitié Salpêtrière AP-HP

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital d'Estaing

    RECRUITING

    Clermont-Ferrand, France

  • Institut Paoli Calmettes

    NOT_YET_RECRUITING

    Marseille, France

  • Saint Louis hospital

    RECRUITING

    Paris, France, 75010, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.