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| Sponsor: | IRCCS San Raffaele |
|---|---|
| Information provided by: | IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT00598624 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndrome Diffuse Large Cell Lymphoma Hodgkin Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma |
Drug: Treosulfan IV |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 175 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: Treosulfan IV
Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
|
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with haematological malignancies, according to WHO classification, such as:
Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD)
A) identity between the 2 CB units and the recipient;
B) Two identical CB units with one or two mismatches with the recipient;
C) Two CB units with one mismatch between them and two mismatches with the recipient. We will prefer mismatches either for class I or for class II antigens; we will avoid mismatches concerning both classes I and II together.
Target graft size (unmanipulated, preferably not cryopreserved)
Exclusion Criteria:
Contacts and Locations| Contact: Luciano LC Callegaro, Monitor | +390226433903 | callegaro.luciano@hsr.it |
| Contact: Stefania ST Trinca, Data Manager | +390226433903 | trinca.stefania@hsr.it |
| Italy | |
| Istituto Europeo di Oncologia - Divisione di Ematologia | Recruiting |
| Milano, Italy | |
| Contact: Liliana Calabrese, Data Manager +390257489536 liliana.calabrese@ieo.it | |
| Principal Investigator: Giovanni Martinelli, MD | |
| AO "Santa Croce" e Carle - Reparto di Ematologia | Recruiting |
| Cuneo, Italy | |
| Contact: Laura Bertolotti, Data Manager +390171642229 laura.bertolotti@libero.it | |
| Principal Investigator: Andrea Gallamini, MD | |
| Ospedale centrale di Bolzano - Reparto di Ematologia | Recruiting |
| Bolzano, Italy | |
| Contact: Enrico Morello, MD +390471908807 enrico.morello@asbz.it | |
| Principal Investigator: Enrico Morello, MD | |
| AOU Santa Maria della Misericordia - Clinica Ematologica | Recruiting |
| Udine, Italy | |
| Contact: Francesca Patriarca, MD patriarca.francesca@aoud.sanita.fvg.it | |
| Principal Investigator: Michela Cerno, MD | |
| USC Ematologia, Ospedali Riuniti | Recruiting |
| Bergamo, Italy | |
| Contact: Anna Grassi, MD agrassi@ospedaliriuniti.bergamo.it | |
| Contact: Maria Luisa Ferrari, DM mlferrari@ospedaliriuniti.bergamo.it | |
| Principal Investigator: Alessandro Rambaldi, MD | |
| PO "R.Binaghi" - CTMO | Recruiting |
| Cagliari, Italy | |
| Contact: Adriana Vacca, MD +393285452813 vaadriana@tiscali.it | |
| Principal Investigator: Giorgio La Nasa, MD | |
| AO San Camillo Forlanini - UOC ematologia e trapianto | Recruiting |
| Roma, Italy | |
| Contact: Beatrice Pinazzi, MD mpinazzi@scamilloforlanini.rm.it | |
| Principal Investigator: Ignazio Majolino, MD | |
| Arcispedale Santa Maria Nuova - SC di Ematologia | Recruiting |
| Reggio Emilia, Italy | |
| Contact: Alessandro Bonini, MD bonini.alessandro@asmn.re.it | |
| Principal Investigator: Luigi Gugliotta, MD | |
| Ospedale Civile - UTI ematologia per il trapianto emopoietico | Recruiting |
| Pescara, Italy | |
| Contact: Paolo Di Bartolomei, MD pescaratmo@virgilio.it | |
| Principal Investigator: Paolo Di Bartolomei, MD | |
| Dipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I | Recruiting |
| Roma, Italy, 00100 | |
| Contact: Emilia Iannella, MD +39 3202233365 emiliaiannella@libero.it | |
| Contact: Roberto Ricci +39 3477578735 r.ricci@bce.uniroma1.it | |
| Principal Investigator: Roberto Foa, MD | |
| Italy, Foggia | |
| Ematologia, Ospedale Casa Sollievo della Sofferenza | Recruiting |
| San Giovanni Rotondo, Foggia, Italy | |
| Contact: Angelo Michele Carella, MD am.carella@operapadrepio.it | |
| Contact: Marzia Tricarico, DM m.tricarico@operapadrepio.it | |
| Principal Investigator: Nicola Cascavilla, MD | |
| Italy, MI | |
| IRCCS San Raffaele; Unità Operativa di Ematologia | Recruiting |
| Milano, MI, Italy, 20100 | |
| Contact: Alessandro Crotta, MD +39 0226433903 a.crotta@hsr.it | |
| Contact: Stefania Trinca +39 0226434289 stefania.trinca@hsr.it | |
| Principal Investigator: Jacopo Peccatori, MD | |
| Study Director: | Fabio FC Ciceri, MD | Unaffiliated |
More Information
| Responsible Party: | IRCCS San Raffaele ( Fabio Ciceri, MD ) |
| Study ID Numbers: | 2005-005182-11 |
| Study First Received: | January 10, 2008 |
| Last Updated: | August 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00598624 History of Changes |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
|
Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Paraproteinemias Hemostatic Disorders Lymphoma, B-Cell Leukemia Preleukemia Pathologic Processes Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Syndrome |
Cardiovascular Diseases Alkylating Agents Lymphoma Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Vascular Diseases Myeloproliferative Disorders Leukemia, Myeloid Pharmacologic Actions |