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Autologous Stem cell Transplantation International Scleroderma ('ASTIS') Trial.


- candidate number1543
- NTR NumberNTR338
- ISRCTNISRCTN54371254
- Date ISRCTN created19-okt-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR11-sep-2005
- Secondary IDsN/A 
- Public TitleAutologous Stem cell Transplantation International Scleroderma ('ASTIS') Trial.
- Scientific TitleHigh dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy.
- ACRONYMASTIS-trial
- hypothesisIt is postulated that the investigational treatment has superior efficacy based on observations of longterm remissions in a number of patients, although this has to be balanced against potentially higher toxicity.
- Healt Condition(s) or Problem(s) studiedSystemic sclerosis
- Inclusion criteriaPatients with diffuse systemic sclerosis, aged 16-65 yrs, and:
1. Disease duration 4 years or less, plus evidence of heart, lung or kidney involvement, plus skin score 15 or more, or:
2. Disease duration 2 years or less, plus evidence of an acute phase reaction in blood, plus skin score 20 or more.
- Exclusion criteriaPatients with concomitant severe disease, extensive pretreatment according to predefined criteria with cyclophosphamide are excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 22-mrt-2001
- planned closingdate1-jan-2008
- Target number of participants200
- InterventionsThis multicenter prospective randomized controlled phase III study compares efficacy and safety of high dose immunoablation and autologous hematopoietic stem cell transplantation (HSCT) (considered the investigational treatment), versus monthly intravenous pulse-therapy cyclophosphamide (considered the control treatment).
The investigational treatment arm comprises the following consecutive steps: mobilization of hematopoietic stem cells with i.v. cyclophosphamide (2x2 gr/m2) and filgrastim (10 mg/kg/day), leukapheresis and selection of CD34+ stem cells, conditioning with i.v. cyclophosphamide (200 mg/kg) and rbATG (7.5 mg/kg), followed by HSCT.
The procedures are normally completed within 3-4 months after randomization. The control treatment arm consists of 12 consecutive monthly i.v. pulses cyclophosphamide (750 mg/m2).
- Primary outcomeThe primary endpoint is event-free survival defined as the time in days from the day of randomization until the occurrence of death or the development of persistent major organ failure (heart, lung, kidney) during the study period of 2 years.
- Secondary outcomeKey secondary outcomes include: treatment related mortality, treatment toxicity, and progression-free survival, defined as the time in days since the day of randomization until death or predefined changes in skin score, organ function, body weight, functional disability from baseline has been documented at two consecutive 3-month evaluations within the study period of 2 years.
- Timepoints
- Trial web sitehttp://www.astistrial.com
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.M. Laar, van
- CONTACT for SCIENTIFIC QUERIESDr. J.M. Laar, van
- Sponsor/Initiator EBMT & EULAR - Autoimmune Disease Working Party (ADWP)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, EULAR, Sangstat, Horton Foundation (Switzerland)
- Publicationsvan Laar JM, Farge D, Tyndall A, on behalf of the EBMT/EULAR Scleroderma Study Group. Stem cell transplantation in systemic sclerosis: hope on the horizon. Ann Rheum Dis 2005, in press.
- Brief summaryThis multicenter prospective randomized controlled phase III study will compare efficacy and safety of high dose immunoablation and autologous hematopoietic stem cell transplantation (HSCT) (considered the investigational treatment), versus monthly intravenous pulse-therapy cyclophosphamide (considered the control treatment) in selected patients with diffuse systemic sclerosis at risk for premature mortality.
The primary endpoint is event-free survival defined as the time in days from the day of randomization until the occurrence of death or the development of persistent major organ failure (heart, lung, kidney) during the study period of 2 years. It is intended to enrol 200 patients and to have an annual follow up of each patient for at least 5 years.
- Main changes (audit trail)
- RECORD11-sep-2005 - 7-mrt-2006


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