Phase II study on the safety and efficacy of fludarabine and threosulfan (14g) (FT14) as a conditioning regimen for Allogeneic Hematopoitic Stem Cell Transplantation for patients with acute myeloid leukemia aged 40 to 65 years

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006515-28-IT

Enrollment

Registered

2022-01-14

Start date

2022-06-07

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML) patients (=40 <65years) MedDRA version: 21.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: FLUDARABINA TEVA - 25 MG/ML CONCENTRATO PER SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO DI VETRO DA 2 ML Product Name: FLUDARABINA Product Code: [FLUDARABINA] Pharmaceutical Form: S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ¿ Patients >40 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ¿ AML patients with t(15;17); t(8;21); inv(16) ¿ Subject has known active CNS involvement with AML. ¿ grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment ¿ Serious organ dysfunction: left ventricular ejection fraction 5 times the upper limit of normal, or creatinine clearance < 40 ml/min. ¿ The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test). ¿ Patients with HIV infection ¿ Current uncontrolled infections ¿ Patients with other life-threatening concurrent disease ¿ Subjects with known hypersensitivity to any of the component medication ¿ Participation in another clinical trial within 1 month before the start of this trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (=40 <65years) in complete morphological remission (CR/CRi/MLFS);Secondary Objective: Cumulative incidence of graft failure at +30 days, +100 days from transplant;Primary end point(s): The 1-year leukemia -free survival (LFS) after allo-SCT;Timepoint(s) of evaluation of this end point: 12 month	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (=40 <65years) in complete morphological remission (CR/CRi/MLFS);Secondary Objective: Cumulative incidence of graft failure at +30 days, +100 days from transplant;Primary end point(s): The 1-year leukemia -free survival (LFS) after allo-SCT;Timepoint(s) of evaluation of this end point: 12 month

—

Secondary

Measure	Time frame
Secondary end point(s): Cumulative incidence of graft failure at +30 days, +100 days from transplant; Cumulative incidence and severity of acute GvHD at 100 days after transplant; Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant; RI at 1 and 2 year after transplantation from days of transplant. - OS at 1 and 2 years post transplant - LFS at 1 and 2 years post transplant; 1 and 2 year probability of GRFS;Timepoint(s) of evaluation of this end point: +30 days, +100 days from transplant; 100 days after transplant; at 1 and 2 years post transplant; at 1 and 2 year after transplantation; 1 and 2 year post transplant	—

Measure

Time frame

Secondary end point(s): Cumulative incidence of graft failure at +30 days, +100 days from transplant; Cumulative incidence and severity of acute GvHD at 100 days after transplant; Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant; RI at 1 and 2 year after transplantation from days of transplant. - OS at 1 and 2 years post transplant - LFS at 1 and 2 years post transplant; 1 and 2 year probability of GRFS;Timepoint(s) of evaluation of this end point: +30 days, +100 days from transplant; 100 days after transplant; at 1 and 2 years post transplant; at 1 and 2 year after transplantation; 1 and 2 year post transplant

—

Countries

Italy

Contacts

Public ContactPROGETTAZIONE RICERCA E STUDI DI FA

ASST SPEDALI CIVILI DI BRESCIA

coordinamento.ricerca@asst-spedalicivili.it0303996125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026