This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
Ematologia, Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
RECRUITINGIRCCS San Raffaele; Unità Operativa di Ematologia
Milan, MI, Italy
RECRUITINGDipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I
Roma, Roma, Italy
RECRUITINGUSC Ematologia, Ospedali Riuniti
Bergamo, Italy
RECRUITINGOspedale centrale di Bolzano - Reparto di Ematologia
Bolzano, Italy
RECRUITINGPO "R.Binaghi" - CTMO
Cagliari, Italy
RECRUITINGAO "Santa Croce" e Carle - Reparto di Ematologia
Cuneo, Italy
RECRUITINGIstituto Europeo di Oncologia - Divisione di Ematologia
Milan, Italy
RECRUITINGOspedale Civile - UTI ematologia per il trapianto emopoietico
Pescara, Italy
RECRUITINGArcispedale Santa Maria Nuova - SC di Ematologia
Reggio Emilia, Italy
RECRUITING...and 2 more locations
Efficacy: Evaluation of engraftment
Time frame: 28 days
Safety: Evaluation of the incidence of CTC grade 3 and 4 adverse events
Time frame: between day -6 and day +28
Efficacy: Evaluation of disease free survival (DFS)
Time frame: 1 year
Efficacy: Evaluation of overall survival (OS)
Time frame: 1 year
Efficacy: Evaluation of relapse incidence (RI)
Time frame: 1 year
Efficacy: Documentation of donor chimerism
Time frame: on day +28, +56 and +100
Safety: Evaluation of incidence of non-relapse mortality (NRM)
Time frame: on day +28 and day +100
Safety: cumulative incidence of NRM
Time frame: 1 year
Safety: Evaluation of cumulative incidence and severity of acute and chronic graft vs. host disease (GvHD)
Time frame: 1 year
Safety: EBV reactivation
Time frame: 1 year
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