Clinical trial · Interventional
Safety and Efficacy of FT14 Conditioning for Allogeneic HSCT in Acute Myeloid Leukemia
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)
NCT07232953CI-TRIAL-00097404FT14active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematopoietic Stem Cell Transplant (HSCT) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine + Treosulfan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine + Treosulfan conditioning regimen in AML patients
- description
- 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.
- interventionNames
- Drug: Fludarabine + Treosulfan
Primary outcomes (1)
- measure
- The 1-year leukemia -free survival (LFS) after allo-SCT
- timeFrame
- From allo-HSCT to 1-year post allo-HSCT
- description
- 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.
Secondary outcomes (14)
- measure
- Cumulative incidence of graft failure at day +30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>40 \<65 years of age * Diagnosis of AML in first complete remission (CR)/complete remission with incomplete recovery (CRi)/multiflow leukemia free state (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 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 \< 40%, FEV1, FVC, DLCO (diffusion capacity) \<40% of predicted, LFT \> 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 diseases * Subjects with known hypersensitivity to any of the component medications * Participation in another clinical trial within 1 month before the start of this trial * Participant, both female and male, in childbearing age who do not agree to maintain an active contraceptive practice * Pregnant or breastfeeding patients during screening
References
Publications (11)
- RESULTShimoni A, Labopin M, Savani B, Hamladji RM, Beelen D, Mufti G, Socie G, Delage J, Blaise D, Chevallier P, Forcade E, Deconinck E, Mohty M, Nagler A. Intravenous Busulfan Compared with Treosulfan-Based Conditioning for Allogeneic Stem Cell Transplantation in Acute Myeloid Leukemia: A Study on Behalf of the Acute Leukemia Working Party of European Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2018 Apr;24(4):751-757. doi: 10.1016/j.bbmt.2017.12.776. Epub 2017 Dec 13. PMID 29247780
- RESULTRuutu T, Volin L, Beelen DW, Trenschel R, Finke J, Schnitzler M, Holowiecki J, Giebel S, Markiewicz M, Uharek L, Blau IW, Kienast J, Stelljes M, Larsson K, Zander AR, Gramatzki M, Repp R, Einsele H, Stuhler G, Baumgart J, Mylius HA, Pichlmeier U, Freund M, Casper J. Reduced-toxicity conditioning with treosulfan and fludarabine in allogeneic hematopoietic stem cell transplantation for myelodysplastic syndromes: final results of an international prospective phase II trial. Haematologica. 2011 Sep;96(9):1344-50. doi: 10.3324/haematol.2011.043810. Epub 2011 Jun 9. PMID 21659356
- RESULTCasper J, Holowiecki J, Trenschel R, Wandt H, Schaefer-Eckart K, Ruutu T, Volin L, Einsele H, Stuhler G, Uharek L, Blau I, Bornhaeuser M, Zander AR, Larsson K, Markiewicz M, Giebel S, Kruzel T, Mylius HA, Baumgart J, Pichlmeier U, Freund M, Beelen DW. Allogeneic hematopoietic SCT in patients with AML following treosulfan/fludarabine conditioning. Bone Marrow Transplant. 2012 Sep;47(9):1171-7. doi: 10.1038/bmt.2011.242. Epub 2011 Dec 12. PMID 22158386
- RESULTWesterhof GR, Ploemacher RE, Boudewijn A, Blokland I, Dillingh JH, McGown AT, Hadfield JA, Dawson MJ, Down JD. Comparison of different busulfan analogues for depletion of hematopoietic stem cells and promotion of donor-type chimerism in murine bone marrow transplant recipients. Cancer Res. 2000 Oct 1;60(19):5470-8. PMID 11034090
- RESULTFichtner I, Becker M, Baumgart J. Antileukaemic activity of treosulfan in xenografted human acute lymphoblastic leukaemias (ALL). Eur J Cancer. 2003 Apr;39(6):801-7. doi: 10.1016/s0959-8049(02)00767-0.