Spots Global Cancer Trial Database for Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
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Trial Identification
Brief Title: Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
Official Title: Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Haematological Malignancies
Study ID: NCT00598624
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ematologia, Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
IRCCS San Raffaele; Unità Operativa di Ematologia, Milano, MI, Italy
USC Ematologia, Ospedali Riuniti, Bergamo, , Italy
Ospedale centrale di Bolzano - Reparto di Ematologia, Bolzano, , Italy
PO "R.Binaghi" - CTMO, Cagliari, , Italy
AO "Santa Croce" e Carle - Reparto di Ematologia, Cuneo, , Italy
Istituto Europeo di Oncologia - Divisione di Ematologia, Milano, , Italy
Ospedale Civile - UTI ematologia per il trapianto emopoietico, Pescara, , Italy
Arcispedale Santa Maria Nuova - SC di Ematologia, Reggio Emilia, , Italy
Dipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I, Roma, , Italy
AO San Camillo Forlanini - UOC ematologia e trapianto, Roma, , Italy
AOU Santa Maria della Misericordia - Clinica Ematologica, Udine, , Italy
Contact Details
Name: Fabio FC Ciceri, MD
Affiliation:
Role: STUDY_DIRECTOR
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