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ACTIVE NOT RECRUITING
NCT07232953
PHASE2

Safety and Efficacy of FT14 Conditioning for Allogeneic HSCT in Acute Myeloid Leukemia

Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, phase II, open-label, non-randomized clinical trial designed to evaluate the safety and efficacy of the Fludarabine plus Treosulfan 14 g/m² (FT14) conditioning regimen for allogeneic stem cell transplantation (allo-SCT) in patients with Acute Myeloid Leukemia (AML) aged 40-65 years who are in complete remission.

Official title: Prospective Phase II Study on Safety and Efficacy of Fludarabine Plus Treosulfan (14g) (FT14) Conditioning Regimen for Allogeneic Stem Cell Transplantation (Allo-SCT) in Acute Myeloid Leukemia (AML) Patients (≥40 <65years) (FT14-Trial)

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2022-11-10

Completion Date

2027-06

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

Fludarabine + Treosulfan

Fludarabine (30 mg/m²/d × 5 days) IV infusion days -6 to -2 and Treosulfan (14 g/m²/d × 3 days) IV infusion days -4 to -2

Locations (13)

Grande Ospedale Metropolitano "Bianco Melacrino Morelli"

Reggio Calabria, Calabria, Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

Naples, Campania, Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Friuli Venezia Giulia, Italy

ASST degli Spedali Civili di Brescia

Brescia, Lombardy, Italy

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

Milan, Lombardy, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, Piedmont, Italy

Ospedali Riuniti di Ancona

Ancona, The Marches, Italy

Ospedale C e G Mazzoni

Ascoli Piceno, The Marches, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Tuscany, Italy

Ospedale dell'Angelo

Mestre, Veneto, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, Italy