Condition: Pediatric Hematopoietic Stem Cell Transplantation · Malignant Disorders · Non-malignant Disorders · Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
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 b…
This description comes directly from the study's public registry record.
Marco Zecca, MD · +390382502848 · m.zecca@smatteo.pv.it
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| Policlinico Sant'Orsola Malpighi, Clinica Pediatrica Oncologia Ed Ematologia Pediatrica "Lalla Seràgnoli" | Bologna, bOLOGNA, Italy | Recruiting |
| Ospedali Civili, Presidio Ospedale Dei Bambini, Oncoematologia Pediatrica e TMO | Brescia, Brescia, Italy | Recruiting |
| IRCCS Istituto Giannina Gaslini, U.O.S.D. Centro Trapianto di Midollo Osseo | Genova, Genova, Italy | Recruiting |
| Ospedale San Raffaele, U.O. Immunoematologia Pediatrica | Milan, Milano, Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori - Clinica Pediatrica | Monza, Monza-brianza, Italy | Recruiting |
| Azienda Ospedaliera di Padova, Oncoematologia Pediatrica | Padova, Padova, Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo, S.C. Ematologia 2 - Oncoematologia Pediatrica | Pavia, Pavia, Italy | Recruiting |
| AOU Città della Salute e della Scienza Di Torino, SC Oncoematologia Pediatrica e Centro Trapianti | Torino, Torino, Italy | Recruiting |
| IRCCS Materno Infantile "Burlo Garofolo", SC Oncoematologia Pediatrica e SS Trapianto Di Midollo | Trieste, Trieste, Italy | Recruiting |
| Ospedale Donna Bambino Azienda Ospedaliera Universitaria Integrata, U.O.C. Oncoematologia Pediatrica | Verona, VR, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06861257