Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
NCT ID: NCT00598624
Last Updated: 2009-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
175 participants
INTERVENTIONAL
2005-09-30
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Treosulfan IV
Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
Interventions
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Treosulfan IV
Treosulfan i.v.: 14 g/m²/d from day -6 to day -4
Eligibility Criteria
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Inclusion Criteria
* acute myeloid leukaemia -AML- in CR1 except "low-risk cases" defined by t(15;17), t(8;21), inv 16 or normal cytogenetics at diagnosis with FLT3-ITD negative and NPM-1 positive, with no high risk clinical criteria
* any AML beyond CR1
* acute lymphoblast leukaemia -ALL- in CR1 only if at "high risk" defined by cytogenetics as t(9;22), t(4;11) or for persistence of minimal residual disease (MRD)
* any ALL beyond CR1
* chronic myeloid leukaemia -CML- in chronic phase (CP) or accelerated phase (AP) intolerant/not responsive to TK-inhibitors
* myeloproliferative disorders -MPD-
* myelodysplastic syndrome -MDS- with intermediate or high risk International Prognostic Scoring System (IPSS)
* diffuse large cell lymphoma -DLCL- with a chemosensitive relapse or beyond CR1
* lymphoblastic and Burkitt lymphoma with a chemosensitive relapse or beyond CR1
* mantle cell lymphoma -MCL- with a chemosensitive relapse or beyond CR1
* follicular lymphoma -FCL- with a chemosensitive relapse or beyond CR2
* Hodgkin lymphoma -HD- with a chemosensitive relapse or beyond CR1
* chronic lymphocytic leukaemia -CLL- at "poor risk" in CR1 or with a chemosensitive relapse
* CLL relapsing after high dose chemotherapy
* T-cell non Hodgkin lymphoma -T-NHL- in CR1 or beyond
* multiple myeloma -MM- at high risk for cytogenetics or ISS stage 3 in CR1 following high dose chemotherapy
* MM at any relapse/progression except refractory disease
2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD)
* HLA-identity defined by the following markers: A, B, DRB1, DQB1 or a single or double Cord Blood unit (CB) with at least a 4 out of 6 HLA-matching by the following markers: A, B and DRB.
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.
3. Target graft size (unmanipulated, preferably not cryopreserved)
* bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or \> 2 x 108 nucleated cells/kg BW recipient or
* peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient
4. Age \> 18 and \< 70 years
5. Karnofsky Index \> 80 %
6. Adequate contraception in female patients of child-bearing potential
7. Written informed consent
Exclusion Criteria
2. Previous allogeneic transplantation
3. Hematopoietic cell transplantation-specific comorbidity index \> 4 (HCT-CI Sorror et al, Appendix M)
4. Known and manifested malignant involvement of the CNS
5. Active infectious disease
6. HIV- positivity or active hepatitis infection
7. Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit)
8. Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
9. Pleural effusion or ascites \> 1.0 L
10. Pregnancy or lactation
11. Known hypersensitivity to treosulfan and/or fludarabine
12. Participation in another experimental drug trial within 4 weeks before day -6
13. Non-co-operative behaviour or non-compliance
14. Psychiatric diseases or conditions that might impair the ability to give informed consent
18 Years
69 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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IRCCS San Raffaele
Principal Investigators
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Fabio FC Ciceri, MD
Role: STUDY_DIRECTOR
Locations
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Ematologia, Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
IRCCS San Raffaele; Unità Operativa di Ematologia
Milan, MI, Italy
Dipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I
Roma, Roma, 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
Milan, , Italy
Ospedale Civile - UTI ematologia per il trapianto emopoietico
Pescara, , Italy
Arcispedale Santa Maria Nuova - SC di Ematologia
Reggio Emilia, , Italy
AO San Camillo Forlanini - UOC ematologia e trapianto
Roma, , Italy
AOU Santa Maria della Misericordia - Clinica Ematologica
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Lazzari L, Ruggeri A, Lupo Stanghellini MT, Mastaglio S, Messina C, Giglio F, Lorusso A, Perini T, Piemontese S, Marcatti M, Lorentino F, Xue E, Clerici D, Corti C, Bernardi M, Assanelli A, Greco R, Ciceri F, Peccatori J. Treosulfan-Based Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation: Long-Term Results From a Phase 2 Clinical Trial. Front Oncol. 2021 Sep 10;11:731478. doi: 10.3389/fonc.2021.731478. eCollection 2021.
Other Identifiers
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2005-005182-11
Identifier Type: -
Identifier Source: org_study_id
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