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Personalized dosing may reduce transplant side effects in kids

NCT ID NCT06861257

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how the chemotherapy drug treosulfan is processed in children getting a stem cell transplant. The goal is to find the right dose for each child to reduce side effects and improve outcomes. Researchers will measure drug levels in the blood and track how patients respond. The study includes 70 children with cancer or other serious blood disorders.

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.

Participants

About 70 people

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

Started

Feb 2021

Expected to finish

Jul 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.

Who is studied

70 pediatric patients (aged 0 to 18 years) affected by malignant or non-malignant disorders and with an indication for HSCT will be enrolled at 13 transplantation sites

Ages

Up to 18 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: * Age range 0 - 18 years. * Life expectancy \> 12 weeks. * Diagnosis of malignant or non-malignant disorder. * Pre-HSCT Lansky / Karnofsky score ≥ 40%. * Indication to allogeneic or autologous HSCT with TREO as part of the pre-transplant conditioning regimen. * Negativity of pregnancy test for female patients. * Written informed consent signed by the parents or guardians. Exclusion Criteria: * Absence of written informed consent signed by the parents or guardians. * Current clinically active infectious disease (including positive HIV serology or viral RNA). * Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \<40%). * Liver dysfunction (AST/ALT ≥ 3 times institutional upper limit normal value -ULN- or bilirubin \> 3 times ULN). * Renal dysfunction: serum creatinine \> 1.5 times ULN or calculated creatinine clearance \< 60 ml/min/1.73 m2 * End stage irreversible multi-system organ failure. * Pregnant or breast feeding female patient.

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Conditions

The condition(s) this trial relates to.

cancer disease

As listed by the trial registrant

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

Malignant disorders Non-malignant disorders Pediatric hematopoietic stem cell transplantation

How to take part

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

  1. The places running it

    10 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

  • AOU Città della Salute e della Scienza Di Torino, SC Oncoematologia Pediatrica e Centro Trapianti

    RECRUITING

    Torino, Torino, 10126, Italy

  • Azienda Ospedaliera di Padova, Oncoematologia Pediatrica

    RECRUITING

    Padova, Padova, 35128, Italy

  • Fondazione IRCCS Policlinico San Matteo, S.C. Ematologia 2 - Oncoematologia Pediatrica

    RECRUITING

    Pavia, Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori - Clinica Pediatrica

    RECRUITING

    Monza, Monza-brianza, 20900, Italy

  • IRCCS Istituto Giannina Gaslini, U.O.S.D. Centro Trapianto di Midollo Osseo

    RECRUITING

    Genova, Genova, 16147, Italy

  • IRCCS Materno Infantile "Burlo Garofolo", SC Oncoematologia Pediatrica e SS Trapianto Di Midollo

    RECRUITING

    Trieste, Trieste, 34137, Italy

  • Ospedale Donna Bambino Azienda Ospedaliera Universitaria Integrata, U.O.C. Oncoematologia Pediatrica

    RECRUITING

    Verona, VR, 37126, Italy

  • Ospedale San Raffaele, U.O. Immunoematologia Pediatrica

    RECRUITING

    Milan, Milano, 20132, Italy

  • Ospedali Civili, Presidio Ospedale Dei Bambini, Oncoematologia Pediatrica e TMO

    RECRUITING

    Brescia, Brescia, 25123, Italy

  • Policlinico Sant'Orsola Malpighi, Clinica Pediatrica Oncologia Ed Ematologia Pediatrica "Lalla Seràgnoli"

    RECRUITING

    Bologna, bOLOGNA, 40138, Italy

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