Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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27 November 2023 |
Main ID: |
EUCTR2011-002434-40-DE |
Date of registration:
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18/08/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the disease
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Scientific title:
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Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosis
Modification according to manifestation
- AST-MOMA |
Date of first enrolment:
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23/03/2012 |
Target sample size:
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44 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002434-40 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Contacts
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Name:
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Department Internal Medicine II
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Address:
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Otfried-Mueller Str. 10
72076
Tuebingen
Germany |
Telephone:
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004970712980681 |
Email:
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joerg.henes@med.uni-tuebingen.de |
Affiliation:
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University Hospital Tuebinegn |
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Name:
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Department Internal Medicine II
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Address:
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Otfried-Mueller Str. 10
72076
Tuebingen
Germany |
Telephone:
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004970712980681 |
Email:
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joerg.henes@med.uni-tuebingen.de |
Affiliation:
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University Hospital Tuebinegn |
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Key inclusion & exclusion criteria
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Inclusion criteria: ? Limited or diffuse cutaneous systemic sclerosis with organ manifestation (lung/heart or kidney) ? Progressive disease despite cyclophosphamide treatment ? Cyclophosphamide i.v.: at least 3 x 500-1000 mg/m² every 3-4 weeks or ? Oral Cyclophosphamide with at least 100mg/day for at least 2 months or ? or contraindications for a cyclophosphamide treatment ? Written informed consent
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: ? Age < 18 years ? Pregnancy or unwillingsness to use contraception ? Concomittend severe disease ? Heart insuffiency with EF < 30% (echo) ? Pulmonary arterial hypertension with papSys > 50mmHg ? Kidney insiffiency with Clearance for creatinine < 30ml/min ? Severe limitation in lung function test ? IVC < 50% ? DLCO = 30% ? Bone marrow defect ? Leukopenia < 2.000/ul ? Thrombopenia < 100.000/ul ? Cyclophosphamide sum dose > 50g (relative) ? Chronic infection (Hepatitis B/C, HIV, salmonella, lues, tuberculosis (relative) ? Severe psychiatric disease ? Abuse of nicotine, alcohol or any illegal drugs ? Poor compliance
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Systemic sclerosis MedDRA version: 14.1
Level: LLT
Classification code 10059040
Term: Autologous peripheral haematopoietic stem cell transplant
System Organ Class: 10042613 - Surgical and medical procedures
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Intervention(s)
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Product Name: CD34 selected autologous hematopoietic cells Product Code: CD34+SC Pharmaceutical Form: Suspension for infusion
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Month 6, 12, 24, 30, 36
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Main Objective: To optimise the treatment for severe systemic sclerosis with high dose chemotherapy and autologous stem cell transplantation by adapting the procedure to the individual organ manifestation.
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Secondary Objective: Reduction of treatment related mortality
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Primary end point(s): Overall survival
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Month 6, 12, 24, 30, 36
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Secondary end point(s): Safety (treatment related mortality/toxicity) Progression free survival Frequency of cardiac manifestations Efficacy (mRSS; sHAQ, DLCO/IVC)
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Source(s) of Monetary Support
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Tuebingen University Hospital
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Ethics review
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Status: Approved
Approval date: 15/03/2012
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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