NCT01895244CompletedPhase 2
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis
Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation
Source: ClinicalTrials.gov · Last updated 29 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful transplantation. Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial. To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to 2x1g. Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 1 Jul 2013
- Start date
- 1 Sept 2012
- Primary completion date
- 30 Sept 2021
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT01895244
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 1 Sept 2012 to the primary completion date, 30 Sept 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously damaged bone marrow
- Previous myelotoxic treatment:
- Severe concomitant psychiatric illness (depression, psychosis)
- Continued drug abuse
Other illness
- Pulmonary arterial hypertension with systolic pulmonary arterial pressure (PAPsys) \>50mm Hg
- Infection (Hepatitis B/C, HIV, Salmonella carrier, syphilis, relative: history of tuberculosis)
Lab values
- Severe heart failure with ejection fraction (EF) \< 30% in echo
- Kidney insufficiency: creatinine clearance \<30 ml/min
Age
- Age \<18 years
Other
- Pregnancy or inadequate contraception
- Reduced lung function
- Inspiratory vital capacity (IVC) \< 50% of normal
- Carbon monoxide (CO)-Diffusion capacity SB \< 40%
- Leukopenia \< 2,000/µl
- Thrombopenia \< 100,000/µl
- Cyclophosphamide \> 50g cumulative (relative)
- Substance dependence
- Continued nicotine abuse
- Continued alcohol abuse
- Consent not given
- Poor compliance
Who the study is looking for
- Diagnosis of progressive systemic sclerosis \<7 years
- Progressive course despite cyclophosphamide pretreatment
- Cyclophosphamide i.v.: at least 3 x with 500-1000 mg/m² every 3-4 weeks or
- Cyclophosphamide p.o. with at least 100mg/day for at least 2 months or
- Contraindication to treatment with cyclophosphamide
- Progress defined as at least one of the following criteria:
- Increase in the mRSS
- Worsening of the lung function
- Increase in fibrosis/alveolitis in thorax CT
- Worsening kidney function through manifestation of systemic sclerosis
- Limited or diffuse cutaneous progressive form of Ssc with organ manifestation in the lungs/heart or kidneys
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.