Treosulfan Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Recipients
NCT ID: NCT06861257
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
70 participants
OBSERVATIONAL
2021-02-24
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
NCT00598624
Treosulfan Pharmacokinetics in Children Undergoing Allogeneic HSCT
NCT02048800
Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome
NCT07316595
Low Dose Treosulfan Based Conditioning Regimen and PTCy in HSCT for Nijmegen Breakage Syndrome
NCT06198842
Dose-range Finding Treosulfan-based Conditioning
NCT01063647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pediatric patients with a indication for HSCT and who will will receive TREO
Pediatric patients (aged 0 to 18 years) affected by malignant or non-malignant disorders and with an indication for HSCT and who will will receive TREO as part of the pre-transplant conditioning regimen, in combination with other chemotherapy agents.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marco Zecca
Head of Pediatric Oncohematology Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Policlinico Sant'Orsola Malpighi, Clinica Pediatrica Oncologia Ed Ematologia Pediatrica "Lalla Seràgnoli"
Bologna, bOLOGNA, Italy
Ospedali Civili, Presidio Ospedale Dei Bambini, Oncoematologia Pediatrica e TMO
Brescia, Brescia, Italy
IRCCS Istituto Giannina Gaslini, U.O.S.D. Centro Trapianto di Midollo Osseo
Genova, Genova, Italy
Ospedale San Raffaele, U.O. Immunoematologia Pediatrica
Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Clinica Pediatrica
Monza, monza-brianza, Italy
Azienda Ospedaliera di Padova, Oncoematologia Pediatrica
Padua, Padova, Italy
Fondazione IRCCS Policlinico San Matteo, S.C. Ematologia 2 - Oncoematologia Pediatrica
Pavia, pavia, Italy
AOU Città della Salute e della Scienza Di Torino, SC Oncoematologia Pediatrica e Centro Trapianti
Torino, torino, Italy
IRCCS Materno Infantile "Burlo Garofolo", SC Oncoematologia Pediatrica e SS Trapianto Di Midollo
Trieste, Trieste, Italy
Ospedale Donna Bambino Azienda Ospedaliera Universitaria Integrata, U.O.C. Oncoematologia Pediatrica
Verona, VR, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Arcangelo Prete
Role: primary
Fulvio Porta
Role: primary
Maura Faraci
Role: primary
Maria Ester Bernardo
Role: primary
Sonia Bonanomi
Role: primary
Elisabetta Calore
Role: primary
Franca Fagioli
Role: primary
Natalia Maximova
Role: primary
Simone cesaro
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TREO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.