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New chemo combo aims to boost leukemia survival after transplant

NCT ID NCT07232953

Disease control Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests a combination of two chemotherapy drugs, fludarabine and treosulfan, given before a stem cell transplant in adults aged 40-65 with acute myeloid leukemia (AML) in remission. The goal is to see if this conditioning regimen improves the chance of being alive and leukemia-free one year after transplant. About 82 participants will receive the treatment and be monitored for safety and effectiveness.

What this could mean

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

Active substance
Fludarabine and Treosulfan (chemotherapy drugs)
What this could lead to
If successful, this conditioning regimen could improve leukemia-free survival after stem cell transplant for AML patients.
What could go wrong
This is a phase 2 trial with only 82 participants, so results may not apply broadly. Chemotherapy can cause serious side effects like infection and organ damage.

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

82 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Jun 2027

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 65 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: * Patients \>40 \<65 years of age * Diagnosis of AML in first complete remission (CR)/complete remission with incomplete recovery (CRi)/multiflow leukemia free state (MLFS) * Eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing (4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1) * Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL) * Adequate renal function (creatinine clearance ≥50 mL/min) * ECOG Performance Status \< 2 * Willing and able to comply with all of the requirements and visits in the protocol. * Written and signed informed consent Exclusion Criteria: * AML patients with t(15;17); t(8;21); inv(16) * Subject has known active CNS involvement with AML. * Grade \>2 NCI-CTCAE (v. 5) adverse events at the time of enrollment * Serious organ dysfunction: left ventricular ejection fraction \< 40%, FEV1, FVC, DLCO (diffusion capacity) \<40% of predicted, LFT \> 5 times the upper limit of normal, or creatinine clearance \< 40 ml/min. * The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test). * Patients with HIV infection * Current uncontrolled infections * Patients with other life-threatening concurrent diseases * Subjects with known hypersensitivity to any of the component medications * Participation in another clinical trial within 1 month before the start of this trial * Participant, both female and male, in childbearing age who do not agree to maintain an active contraceptive practice * Pregnant or breastfeeding patients during screening

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukaemia (AML) Hematopoietic stem cell transplant (HSCT)

Contacts and locations

Locations

  • ASST degli Spedali Civili di Brescia

    Brescia, Lombardy, 25123, Italy

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, Piedmont, 12100, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37126, Italy

  • Azienda Ospedaliera Universitaria di Modena

    Modena, Emilia-Romagna, 41124, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Fondazione IRCCS Ca&#39; Granda Ospedale Maggiore Policlinico,

    Milan, Lombardy, 20122, Italy

  • Grande Ospedale Metropolitano "Bianco Melacrino Morelli"

    Reggio Calabria, Calabria, 89124, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Ospedale C e G Mazzoni

    Ascoli Piceno, The Marches, 63100, Italy

  • Ospedale dell'Angelo

    Mestre, Veneto, 30174, Italy

  • Ospedali Riuniti di Ancona

    Ancona, The Marches, 60126, Italy

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