Status:
COMPLETED
Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Aplastic Anemia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG, Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe aplastic anaemia, and ...
Detailed Description
Traditionally horse antithymocyte globulin (ATG) has been the preferred animal source of ATG as first line treatment for acquired aplastic anaemia (AA) patients who are ineligible for bone marrow tran...
Eligibility Criteria
Inclusion
- Must fulfil definition of 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
- 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
- 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
- Have acquired aplastic anaemia
- Time from diagnosis to study registration maximum 6 months
- No prior treatment except for haemopoietic growth factors given for no more than four weeks, and androgens
- Age minimum 16 years with no upper age limit
Exclusion
- Eligibility for an human leukocyte antigens (HLA)-matched sibling donor transplant for SAA patients
- Prior therapy with ATG or CSA
- Haematopoeitic growth factors more than 4 weeks before study enrolment
- Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
- Evidence of myelodysplastic disease
- Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of Paroxysmal Nocturnal Hemoglobinuria (PNH) associated thrombosis or a PNH clone \>50% by flow cytometry
- Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
- Subject is pregnant (e.g. positive Human Chorionic Gonadotropin (HCG) test) or is breast feeding
- Severe uncontrolled infection or unexplained fever \>38 degrees Celsius
- Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00471848
Start Date
August 1 2008
End Date
February 1 2013
Last Update
September 26 2023
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Henri Mondor Hospital
Créteil, France
2
Hopital St. Louis
Paris, France, 75475
3
University Hospital Essen
Essen, Germany
4
University Hospital Eppendorf
Hamburg, Germany