Status:
UNKNOWN
EBMT ADWP Prospective Non-interventional Study: Post-AHSCT Management in SSC Patients (NISSC-2)
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to assess the effectiveness of various post-transplant treatment management approaches on clinical and immune biological responses after Autologous Hematopoietic Stem Cell tran...
Detailed Description
NISSc-2 is a prospective observational study specifically designed to assess the effectiveness of various post-transplant treatment management approaches on clinical and immune biological responses af...
Eligibility Criteria
Inclusion
- \- Autologous HSCT
- \- Age above 18 years at time of transplant.
- -. Established diagnosis of progressive SSc according to 2013 ACR/EULAR classification criteria
Exclusion
- Pregnancy or inadequate contraception
- Severe concomitant disease
- Reduced lung, cardiac or renal function
- a. .Reduced lung function with FVC \< 50% or DLCO \< 30% (of predicted values) b; .Pulmonary arterial hypertension with baseline (resting) PASP \> 40 mmHg or mPAP \> 25 mmHg or a PASP \> 45 mmHg or mPAP \> 30 mmHg after fluid challenge or Pulmonary vascular resistance \> 3 Wood units on RHC c. Severe heart failure with Ejection Fraction \< 45% by cardiac echocardiography d. D-sign of septal bounce on cardiac MRI e. Unrevascularized severe coronary artery disease f. Untreated severe arrhythmia g. Cardiac tamponade h. Constrictive pericarditis i. Kidney insufficiency: creatinine clearance \<30ml/min Previously damaged bone marrow
- Leukopenia \< 2.0 x 109/L (total white cell count)
- Thrombocytopenia \< 100 x 109/L
- Uncontrolled severe or chronic infection (Hepatitis B/C, HIV, Salmonella carrier, syphilis, tuberculosis)
- Severe concomitant psychiatric illness (depression, psychosis)
- Concurrent neoplasms or myelodysplasia in the past 5 years
- Smoking (current)
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03444805
Start Date
July 1 2019
End Date
March 30 2023
Last Update
September 3 2019
Active Locations (1)
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1
Badoglio Manuela- EBMT Paris Office
Paris, France, 75010