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New hope for older AML patients: gentler transplant approach aims to boost survival with less toxicity

NCT ID NCT07598110

Disease control Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 reduced-intensity chemotherapy combination (fludarabine and treosulfan) before a half-matched stem cell transplant in 77 older or frail adults with AML. The goal is to see if this gentler regimen can control the leukemia long-term while being safe enough for patients who cannot tolerate standard high-dose chemo. Participants will receive the transplant and then be followed for relapse and 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 77 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2031

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

18 to 75 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: * Patient with age between 60 and 75 years old ; or aged 18-59 years if considered by the investigator for any reason as ineligible for MAC regimen (as defined by the EBMT criteria17), notably in case of HCT-CI ≥ 3 (patients planned by the investigators to receive a RIC regimen in clinical routine practice); * Patients with AML according to the ELN2022 classification criteria requiring allo-HSCT including the MDS/AML sub category); * Less than 5% bone marrow blast at the time of inclusion (i.e. CR, CRi, CRh, or MLFS after prior treatment, according to ELN 2022); * Allo-HSCT planed with a haploidentical donor; * Covered by a Healthcare System; * Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. Exclusion Criteria: * Left ventricular function \< 40% ; * Renal clearance \< 50 mL/min ; * Any severe uncontrolled medical condition considered by the investigator as a contraindication for using treosulfan; * Pregnant women or those who may become pregnant (without effective contraception) or breastfeeding; * Adults under legal protection (guardianship, curatorship, or judicial protection); * Inability to comply with the medical follow-up of the trial for geographical, social, or psychological reasons.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

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  1. 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 ↗

  2. A doctor treating you

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