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

NCT07232953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukaemia (AML)
  • Hematopoietic Stem Cell Transplant (HSCT)

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

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Domenico Russo, MD · ASST Spedali Civili di Brescia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232953 on ClinicalTrials.gov