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NCT06861257
Treosulfan Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Recipients
trial in Pediatric Hematopoietic Stem Cell Transplantation in 70 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 70 |
| Start date | 24 February 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 10 locations across Italy |
Conditions studied
- Pediatric Hematopoietic Stem Cell Transplantation — all drugs for Pediatric Hematopoietic Stem Cell Transplantation →
- Malignant Disorders — all drugs for Malignant Disorders →
- Non-malignant Disorders — all drugs for Non-malignant Disorders →
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Who can join
Under 18, any sex, with Pediatric Hematopoietic Stem Cell Transplantation or Malignant Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One of the major challenges to improve the outcome of hematopoietic stem cell transplantation (HSCT) is the reduction of toxicity and non-relapse mortality caused by the pre-transplant conditioning regimen, while maintaining efficacy. Treosulfan (TREO) (L-treitol-1,4-bis-methanesulfonate) is a busulfan analogue with a distinct site of alkylation that results in a more favourable toxicity profile in comparison with busulfan and total body irradiation. TREO is the prodrug of L-epoxybutane, a water-soluble bifunctional alkylating agent with remarkable myeloablative and immunosuppressive properties. The use of TREO, in combination with other chemotherapy agents, as part of the conditioning regimen for hematopoietic stem cell transplantation (HSCT) in children has progressively increased during the last decade for both malignant and non-malignant disorders. Data on TREO pharmacokinetics in the pediatric population are still scarce. To date, only a few studies, including small numbers of pediatric patients, have investigated the PK profile of TREO. These studies reported high variability of TREO pharmacokinetics, and the relationship between TREO exposure, toxicity and clinical outcome is still unresolved. Therefore, therapeutic drug monitoring with a personalized approach may be an important tool to optimize outcomes in the pediatric population. The aim of the investigators' study is to characterize TREO PK/PD profiles in children undergoing HSCT and to evaluate the relationship between TREO exposure and early toxicity and clinical outcome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06861257 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Policlinico San Matteo di Pavia
- Last refreshed: 10 March 2025
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