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)
Key facts
- Where
- Ancona, Ascoli Piceno, Brescia, Catania, Cuneo, Florence, Milan, Modena, Monza, Naples, Reggio Calabria, Roma, Rome, Udine, Venice és Verona, OlaszországSee the 17 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Olaszország
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, OlaszországToborzás még nem indult
- Azienda Sanitaria Territoriale di Ascoli PicenoAscoli Piceno, OlaszországToborzás még nem indult
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországToborzás még nem indult
- Azienda Ospedaliera Santa Croce E CarleCuneo, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria CareggiFlorence, OlaszországToborzás még nem indult
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországToborzás még nem indult
- Istituto San RaffaeleMilan, OlaszországToborzás még nem indult
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországToborzás még nem indult
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországToborzás még nem indult
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, OlaszországToborzás még nem indult
- Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, OlaszországToborzás még nem indult
- Ospedale S. EugenioRoma, OlaszországToborzás még nem indult
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországToborzás még nem indult
- Azienda Sanitaria Universitaria Friuli CentraleUdine, OlaszországToborzás még nem indult
- Azienda Ulss 3 SerenissimaVenice, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Trial code
- EU 2024-520326-11-00
- Record updated
- 2025. január 31.
- Original description
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)Read full original descriptionShow less
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)
Inclusion: Patients >40 <65 years of age; Diagnosis of AML in first CR/CRi/ MLFS; Eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing (4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1); Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL); Adequate renal function (creatinine clearance ≥50 ml/min); ECOG Performance Status < 2; Willing and able to comply with all of the requirements and visits in the protocol; Written and signed informed consent.
Exclusion: Participation in another clinical trial within 1 month before the start of this trial; Patients with other life-threatening concurrent disease; The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test); Patients with HIV infection; Current uncontrolled infections; Subjects with known hypersensitivity to any of the component medication; Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min; Participant, both female and male, in childbearing age who do not agree to maintain active contraceptive practice; AML patients with t(15;17); t(8;21); inv(16); Pregnant or lacting patients during screening; Subject has known active CNS involvement with AML; Grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment.