2024-520326-11-00Not yet recruitingPhase 2
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 30 Sept 2022
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Diseases
- Acute myeloid leukemia
- EU CT number
- 2024-520326-11-00
- EudraCT number
- 2022-003206-69
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 82
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged over 40 and under 65 with acute myeloid leukemia (AML) in first remission who can have a stem cell transplant from an HLA-identical related or unrelated donor.
- Age
- Over 40 and under 65 years
- Sex
- All sexes
- Disease stage
- AML in first complete remission (CR/CRi/MLFS)
- Biomarker or test result
- Donor with identical HLA type at HLA-A, B, C and DRB1 (4-digit typing)
Main reasons for not taking part
- AML with t(15;17), t(8;21) or inv(16)
- Active involvement of the central nervous system by AML
- Serious organ problems (heart, lung, liver or kidney)
- Active HBV or HCV infection, or HIV infection
- Pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within 1 month before the start of this trial
- Patients with other life-threatening concurrent disease
Other illness
- 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
Lab values
- 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
Age
- Participant, both female and male, in childbearing age who do not agree to maintain active contraceptive practice
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi | Ancona | Italy | Not yet recruiting |
| Azienda Sanitaria Territoriale di Ascoli Piceno | Ascoli Piceno | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Italy | Not yet recruiting |
| Azienda Ospedaliera Santa Croce E Carle | Cuneo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Not yet recruiting |
| Istituto San Raffaele | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Not yet recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli | Naples | Italy | Not yet recruiting |
| Grande Ospedale Metropolitano Bianchi Melacrino Morelli | Reggio Calabria | Italy | Not yet recruiting |
| Ospedale S. Eugenio | Roma | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale | Udine | Italy | Not yet recruiting |
| Azienda Ulss 3 Serenissima | Venice | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.