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NCT07232953: FT14
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)
Phase 2 trial testing Fludarabine + Treosulfan in Acute Myeloid Leukaemia (AML) in 82 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2026
Quick facts
| Lead sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 10 November 2022 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 13 locations across Italy |
Drugs / interventions tested
- Fludarabine + Treosulfan — full drug profile →
Conditions studied
- Acute Myeloid Leukaemia (AML) — all drugs for Acute Myeloid Leukaemia (AML) →
- Hematopoietic Stem Cell Transplant (HSCT) — all drugs for Hematopoietic Stem Cell Transplant (HSCT) →
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →
Who can join
Adults 40 to 65, any sex, with Acute Myeloid Leukaemia (AML) or Hematopoietic Stem Cell Transplant (HSCT). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The 1-year leukemia -free survival (LFS) after allo-SCT
Time frame: From allo-HSCT to 1-year post allo-HSCT
Proportion of patients alive and free from leukemia at 1 year after allogeneic hematopoietic stem cell transplantation (allo-HSCT), estimated using the Kaplan-Meier method.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07232953
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Myeloid Leukaemia (AML)
Currently open trials in the same condition.
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- NCT07244367 — Maintenance Venetoclax in AML Fit Patients · NA · recruiting
Other Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia trials
Trials by the same sponsor.
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- NCT05738902 — Adherence and Compliance to ERAS in Gynecological Surgery · unknown
- NCT06765343 — Efficacy of Guided Biofilm Therapy in Pediatric Patient · NA · completed
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 NCT07232953 (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 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Last refreshed: 16 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07232953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing