Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)
NCT ID: NCT01163942
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
205 participants
INTERVENTIONAL
2001-03-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No G-CSF, No 2nd ATG
Patients randomised not to receive G-CSF (alongside ATG and CSA) and to not receive early retreatment in case of no response.
G-CSF
Yes/no addition of G-CSF
Early retreatment with ATG
Yes/no early retreatment with ATG
No G-CSF, yes 2nd ATG
Patients randomised not to receive G-CSF (alongside ATG and CSA) but they do receive early retreatment in case of no response.
G-CSF
Yes/no addition of G-CSF
Early retreatment with ATG
Yes/no early retreatment with ATG
Yes G-CSF, No 2nd ATG
Patients randomised to receive G-CSF (alongside ATG and CSA) and to not receive early retreatment in case of no response.
G-CSF
Yes/no addition of G-CSF
Early retreatment with ATG
Yes/no early retreatment with ATG
Yes G-CSF, Yes 2nd ATG
Patients randomised to receive G-CSF (alongside ATG and CSA) and to receive early retreatment in case of no response.
G-CSF
Yes/no addition of G-CSF
Early retreatment with ATG
Yes/no early retreatment with ATG
Interventions
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G-CSF
Yes/no addition of G-CSF
Early retreatment with ATG
Yes/no early retreatment with ATG
Eligibility Criteria
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Inclusion Criteria
* Less than 6 months from diagnosis of severe aplastic anemia by bone marrow biopsy
* Ethical - Before randomization is done the subject or legally acceptable representative must give written informed consent for participation in the study
Exclusion Criteria
* Prior therapy with ATG
* Cyclosporin A \<4 weeks before enrollment
* Treatment with G-CSF \<2 weeks before enrollment
* Other growth factors \<4 weeks before enrollment
* Diagnosis of Fanconi anemia, dyskeratosis congenita or congenital bone marrow failure syndrome
* Evidence of myelodysplastic disease
* Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
* Subjects who have infection, hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that death is imminent
* Subject is pregnant (e.g. positive HCG test) or is breast feeding
2 Years
90 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
European Society for Blood and Marrow Transplantation
NETWORK
Responsible Party
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Principal Investigators
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André Tichelli, Prof. MD.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital
Pilsen, , Czechia
CHU Angers
Angers, , France
Avicenne Hospital
Bobigny, , France
University Hospital
Brest, , France
CHU Clemenceau
Caen, , France
CHU de Caen
Caen, , France
Henri Mondor
Créteil, , France
CHU Limoges
Limoges, , France
Paoli-Calmettes Institute
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Caremeau
Nîmes, , France
St. Antoine
Paris, , France
St. Louis Hospital
Paris, , France
CHU Reims
Reims, , France
CHU Toulouse
Toulouse, , France
Bretonneau Hospital
Tours, , France
G. Roussy Institute
Villejuf, , France
Benjamin Franklin Hospital
Berlin, , Germany
Charite Hospital
Berlin, , Germany
Evangelisches Waldkrankenhaus
Berlin, , Germany
Evangelisches Krankenhaus Diakonie
Bremen, , Germany
University Hospital
Cologne, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
St. Johannes-Hospital
Duisburg, , Germany
University Hospital Heinrich Heine
Düsseldorf, , Germany
Universitätsklinik
Essen, , Germany
University Hospital
Frankfurt, , Germany
University Hospital Georg August
Göttingen, , Germany
Marien Hopistal
Hagen, , Germany
University Hospital
Halle, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
University Hospital
Heidelberg, , Germany
Universitäts Klinikum
Ludwigshaven, , Germany
Sana Klinikum
Lübeck, , Germany
Harlachin
München, , Germany
Klinkum Rechts der Isar
München, , Germany
Krakenhaus München Schwabing
München, , Germany
Klinikum Nord
Nuremberg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Brüderkrankenhaus St. Josef
Paderborn, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
University Hospital
Regensburg, , Germany
University Hospital
Rostock, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
University Clinic Tübingen
Tübingen, , Germany
University Hospital Ulm
Ulm, , Germany
Deutsche Klinik für Diagnostik
Wiesbaden, , Germany
University Hospital
Wiesbaden, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Athens General Pediatric Hospital
Athens, , Greece
University Hospital
Pátrai, , Greece
Gaslini Children's Hospital
Genova, , Italy
San Martino
Genova, , Italy
San Raffaele Hospital
Milan, , Italy
University Hospital
Padua, , Italy
Groningen University Hospital
Groningen, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Lund Unversity
Lund, , Sweden
Huddinge University Hospital
Stockholm, , Sweden
University Hospital
Basel, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Monklands Hospital
Airdrie, , United Kingdom
Heartlands Hospital
Birmingham, , United Kingdom
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
Royal Cornwall Hospitals
Cornwall, , United Kingdom
The Leeds Teaching Hospitals
Leeds, , United Kingdom
St George's Hospital/ St George's University of London
London, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
Wishaw General
Wishaw, , United Kingdom
Countries
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References
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Tichelli A, de Latour RP, Passweg J, Knol-Bout C, Socie G, Marsh J, Schrezenmeier H, Hochsmann B, Bacigalupo A, Samarasinghe S, Rovo A, Kulasekararaj A, Roth A, Eikema DJ, Bosman P, Bader P, Risitano A, Dufour C; SAA Working Party of the EBMT. Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation. Haematologica. 2020 May;105(5):1223-1231. doi: 10.3324/haematol.2019.222562. Epub 2019 Oct 3.
Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.
Other Identifiers
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41980964
Identifier Type: REGISTRY
Identifier Source: secondary_id
Flagship AA trial
Identifier Type: -
Identifier Source: org_study_id
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