Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
AlloTreo
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
1 other identifier
interventional
175
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Sep 2005
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 11, 2009
August 1, 2009
4.3 years
January 10, 2008
August 10, 2009
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy: Evaluation of engraftment
28 days
Safety: Evaluation of the incidence of CTC grade 3 and 4 adverse events
between day -6 and day +28
Secondary Outcomes (8)
Efficacy: Evaluation of disease free survival (DFS)
1 year
Efficacy: Evaluation of overall survival (OS)
1 year
Efficacy: Evaluation of relapse incidence (RI)
1 year
Efficacy: Documentation of donor chimerism
on day +28, +56 and +100
Safety: Evaluation of incidence of non-relapse mortality (NRM)
on day +28 and day +100
- +3 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with haematological malignancies, according to WHO classification, such as:
- 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
- +15 more criteria
You may not qualify if:
- Secondary malignancies
- Previous allogeneic transplantation
- Hematopoietic cell transplantation-specific comorbidity index \> 4 (HCT-CI Sorror et al, Appendix M)
- Known and manifested malignant involvement of the CNS
- Active infectious disease
- HIV- positivity or active hepatitis infection
- Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit)
- Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
- Pleural effusion or ascites \> 1.0 L
- Pregnancy or lactation
- Known hypersensitivity to treosulfan and/or fludarabine
- Participation in another experimental drug trial within 4 weeks before day -6
- Non-co-operative behaviour or non-compliance
- Psychiatric diseases or conditions that might impair the ability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Ematologia, Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
IRCCS San Raffaele; Unità Operativa di Ematologia
Milan, MI, 20100, Italy
Dipartimento Biotecnologie Cellulari ed Ematologia; Azienda Policlinico Umberto I
Roma, Roma, 00100, 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
Related Publications (1)
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.
PMID: 34568066DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabio FC Ciceri, MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 22, 2008
Study Start
September 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
August 11, 2009
Record last verified: 2009-08