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Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants
EU CTIS ID: 2023-505877-34-00
What this study is testing
To determine the optimal treatment strategy in early dcSSc: the effect of HSCT as upfront therapy compared with that of immunosuppressive medication in early dcSSc, with respect to survival and prevention of major organ failure (reflected in the Global Rank Composite Score, the primary endpoint).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 65 years.
- Fulfilling the 2013 ACR-EULAR classification criteria
- Disease duration ≤ 3 years (from onset of first non-Raynaud's symptoms) and -mRSS ≥ 15 (diffuse skin pattern) and/ or - clinically significant organ involvement as defined by either: a) respiratory involvement b) renal involvement c) cardiac involvement, OR Disease duration ≤ 1 year and diffuse cutaneous disease with mRSS>10 and high risk ANA for organ based disease and/or acute phase response
You likely can't join if
- Pregnancy or unwillingness to use adequate contraception during study
- concomitant severe disease (respiratory, renal, cardiac, liver failure, psychiatric disorders, concurrent neoplasms or myelodysplasia, bone marrow insufficiency, uncontrolled hypertension, uncontrolled acute or chronic infection, ZUBROD-ECOG-WHO PSS > 2, known hypersensitivity to any of the study drug constituents)
- Previous treatments with immunosuppressants > 12 months including MMF, methotrexate, azathioprine, rituximab, tocilizumab, glucocorticosteroids.
- Previous treatments with TLI, TBI or alkylating agents including CYC.
- Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica
- eosinophilic myalgia syndrome; eosinophilic fasciitis
See the full eligibility criteria
- Age between 18 and 65 years.
- Fulfilling the 2013 ACR-EULAR classification criteria
- Disease duration ≤ 3 years (from onset of first non-Raynaud's symptoms) and -mRSS ≥ 15 (diffuse skin pattern) and/ or - clinically significant organ involvement as defined by either: a) respiratory involvement b) renal involvement c) cardiac involvement, OR Disease duration ≤ 1 year and diffuse cutaneous disease with mRSS>10 and high risk ANA for organ based disease and/or acute phase response
- Pregnancy or unwillingness to use adequate contraception during study
- concomitant severe disease (respiratory, renal, cardiac, liver failure, psychiatric disorders, concurrent neoplasms or myelodysplasia, bone marrow insufficiency, uncontrolled hypertension, uncontrolled acute or chronic infection, ZUBROD-ECOG-WHO PSS > 2, known hypersensitivity to any of the study drug constituents)
- Previous treatments with immunosuppressants > 12 months including MMF, methotrexate, azathioprine, rituximab, tocilizumab, glucocorticosteroids.
- Previous treatments with TLI, TBI or alkylating agents including CYC.
- Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica
- eosinophilic myalgia syndrome; eosinophilic fasciitis
- Poor compliance of the patient as assessed by the referring physicians
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.