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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-002562-19-IT
Date of registration: 24/01/2007
Prospective Registration: No
Primary sponsor: Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova
Public title: Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT
Scientific title: Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT
Date of first enrolment: 21/04/2006
Target sample size: 12
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002562-19
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: n.bracci non previsto If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
- Age between 18 and 50 Clinically and laboratory definite RRMS or RP EDSS score between 3 and 6.5 Documented rapid progression over the previous year despite conventional therapies immunomodulating and immunosuppressive treatments, see below; progression is defined as a worsening of 1 or more EDSS points between 3 and 6 or 0.5 or more between 6 and 6.5 or at least three relapses in the previous year also without progression of the disease despite conventional therapies immunomodulating and immunosuppressive treatments, see below Presence of at least 1 enhancing area on brain MRI using a triple dose TD of Gd Previous treatment with immunomodulating drugs interferon beta or glatiramer acetate without efficacy Previous treatment with immunosuppressive drugs Mitoxantrone or CY at standard dosage without efficacy Acceptance of using a valid birth control
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Primary progressive or Secondary Progressive MS Relapse in the last 30 days Previous treatment with TBI or TLI Treatment with Interferons, Cop1 or steroids in the last month Treatment with CY, Mitoxantrone, Aza, or other immunosuppressant in the last 3 months Concomitant diseases of lungs, kidneys, liver, heart, endocrine or neurological systems, Infectious illnesses, Psychiatric disturbances Left ventricular ejection fraction 50 , unexplained ECG abnormalities History of recurrent urinary tract infections or respiratory infections Pregnancy, breast feedings, patient s non compliance to use birth control methods Contraindications for MRI


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
VERIFICARE Patients with multiple sclerosis, age between 18 and 50
MedDRA version: 6.1 Level: PT Classification code 10028245
Intervention(s)

Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE

Product Name: Thymoglobuline
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Antithymocyte
Current Sponsor code: LIGHT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Endoxan - ciclofosfamide
Product Name: Endoxan
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Cyclophosfamide
Current Sponsor code: LIGHT
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)
Main Objective: The objective is therefore the search of a new light immunoablative regimen, with a better safety profile than BEAM but with a similar efficacy.
Primary end point(s): The primary endpoint of the study is to evaluate the safety and the effect on Gd-enhanced MRI of ASCT using a new conditioning regimen CY 120 mg/Kg followed by ATG in a population of severe MS cases, with clinical and MRI signs of disease activity, unresponsive to conventional immunomodulating and immunosuppressive therapy.
Secondary Objective: Obtain information on the clinical course progression, evaluated with EDSS and MSFC or number or relapses in the 24 months following ASCT. Collect other MRI data, such as brain atrophy, total lesion load, new T2 lesions, diffusion tensor imaging, after 1 and 2 years from ASCT. Study of the immunological recovery and regeneration of the immune repertoire after ASCT Effect of the treatment on fertility Quality of life outcome evaluation
Secondary Outcome(s)
Secondary ID(s)
LIGHT
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
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