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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:  EUCTR2007-000902-55-FR
Date of registration: 04/10/2007
Prospective Registration: Yes
Primary sponsor: EBMT (European group for Blood and Marrow Transplantation)
Public title: Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin
Scientific title: Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin
Date of first enrolment: 23/04/2008
Target sample size: 35
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000902-55
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Historical patient cases If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Historical cases treated with Horse Antithymoglobuline  
Phase: 
Countries of recruitment
France Germany United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1.To define aplastic anaemia there must be at least two of the following:
· haemoglobin < 10g/dl
· platelet count < 50 x 109/l
· neutrophil count < 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy

1.1 SAA as defined by a hypocellular bone marrow of <25% cellularity and two of the following:
· neutrophil count < 0.5 x 109/l,
· platelets < 20 x 109/l
· reticulocytes < 20 x 109/l

1.2 NSAA as defined by a hypocellular bone marrow and cytopenia in at least two cell lines and neutrophil count > 0.5 x 109/l, and red cell and/or platelet transfusion dependence

1.3 Acquired AA

2.Time from diagnosis to study registration = 6mths

3. No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens

4. Age = 16yrs (= 18yrs in Germany in accordance with German law), with no upper age limit

Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Eligibility for an HLA-matched sibling donor transplant for SAA patients.

2. Prior therapy with ATG or CSA

3. Haematopoeitic growth factors more than 4 weeks before study enrollment

4. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome

5. Evidence of myelodysplastic disease

6. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone > 50% by flow cytometry

7. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)

8. Subject is pregnant (e.g. positive HCG test) or is breast feeding

9. Severe uncontrolled infection or unexplained fever > 38oC

10. Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 9.1 Level: LLT Classification code 10002274 Term: Anemia aplastic
Intervention(s)

Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 87867-94-5
Other descriptive name: GLYCINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
CAS Number: 69-65-8
Other descriptive name: Mannitol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Neoral
Product Name: Ciclosporine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Cyclosporin A
CAS Number: 59865-13-3
Other descriptive name: Ciclosporine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with Ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent.
Primary end point(s): is response at 6 months post treatment
Secondary Objective: To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).
Secondary Outcome(s)
Secondary ID(s)
2007-000902-55-GB
RATGAA07
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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